FibrosisPhase 1NCT04931147
A 3-part Study to Evaluate Safety, Tolerability, Food Effect and Drug-drug Interactions of RXC007 in Healthy Volunteers
A Phase 1 study testing RXC007 in people with Fibrosis and Inflammation, run by Redx Pharma Ltd at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of RXC007. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fibrosis, Inflammation, Idiopathic Pulmonary Fibrosis
- What is being tested?
- RXC007
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 May 2021to 8 Mar 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male participants, between 18 and 55 years of age, inclusive.
- Male participant (and female partner of childbearing potential) willing to use a highly effective method of contraception or 2 effective methods of contraception, if applicable (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the participant) from first dose until 3 months after last dose of IMP/NIMP.
- Participant with a body mass index (BMI) of 18.0-32.0 kg/m2.
- Participant with a body weight of 60 kg or greater.
- No clinically significant history of previous allergy / sensitivity to RXC007, rosuvastatin or metformin, or any of the excipients contained within the IMP/NIMP.
- No clinically significant abnormal test results for serum biochemistry, haematology and/or urine analyses within 28 days before the first dose administration of the IMP/NIMP.
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- Haemoglobin and haematocrit above the lower limit of the normal range for the reference laboratory.
- Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) < 1.5 times the upper limit of the normal (ULN) range for the reference laboratory.
- Participant with a negative urinary drugs of abuse (DOA) screen (including alcohol) test results, determined within 28 days before the first dose administration of the IMP/NIMP (N.B.: A positive test result may be repeated at the Investigator's discretion).
- Participant with negative human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCV Ab) test results at Screening.
- No clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 28 days before first dose of IMP/NIMP including a PR interval > 220ms, QRS width > 120ms and QTcF interval > 450 ms.
- No clinically significant abnormalities in vital signs (e.g., blood pressure (systolic blood pressure > 140 mmHg) / heart rate, respiration rate, oral temperature) determined within 28 days before first dose of IMP/NIMP.
- Participant must be available to complete the study (including all follow-up visits).
- Participant must satisfy an Investigator about his fitness to participate in the study.
- Participant must provide written informed consent to participate in the study.
- Participants with a negative COVID-19 reverse transcription polymerase chain reaction (RT-PCR) test on admission (if required).
Who cannot join
- A clinically significant history of gastrointestinal disorder likely to influence IMP/NIMP absorption.
- A clinically significant history of infection in the last 3 months.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements, antacids (Part C Cohort 1 only), any product known to be a substrate mainly metabolised by CYP enzymes within 28 days or 5 half-lives (whichever is longer) prior to the first dose of IMP/NIMP.
- Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- Participants who are unable to demonstrate the ability to swallow multiple "dummy" capsules (i.e., an empty gelatin capsules) of the size proposed for administration in a particular cohort/dose level (up to and including size 00).
- Participant with a glomerular filtration rate less than 80 mL/min/1.73m2 (calculated by Cockcroft-Gault equation.
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- A clinically significant history of drug or alcohol abuse (defined as the consumption of more than 14 units of alcohol a week) within the past two years.
- Inability to communicate well with the Investigators (i.e., language problem, poor mental development or impaired cerebral function).
- Participation in a NCE clinical study within the previous 3 months or five half-lives, whichever is longer, or a marketed drug clinical study within the 30 days or five half-lives, whichever is longer, before the first dose of IMP/NIMP. (Washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).
- Donation of 450 mL or more blood within the 3 months before the first dose of IMP/NIMP.
- Vegans, vegetarians or other dietary restrictions (e.g., restrictions for medical, religious or cultural reasons, etc.), which would prevent participants from consuming a high-fat breakfast or standardised meal.
- Users of nicotine products i.e., current smokers or ex-smokers who have smoked within the 6 months prior to screening or users of cigarette replacements (i.e., e-cigarettes, nicotine patches or gums).
- Participants who have received a COVID-19 vaccine injection within 28 days prior to the first dose of IMP/NIMP.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Simbec-Orion Clinical Pharmacology
Merthyr Tydfil, Mid Glamorgan, CF48 4DR
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, SAD/MAD First-in-human, Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RXC007 Including Evaluation of Drug-Drug Interaction and Food Effect in Male Participants
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of RXC007.
Read the detailed description
The study will be split into 3 parts: Part A, Part B \& Part C.
The overall study will enrol up to 136 healthy males; maximum of 68 in Part A, maximum of 44 in Part B and maximum of 24 in Part C.
The purpose of Part A is to evaluate the safety, tolerability and concentration of RXC007 in the blood when it is given as a single dose on one occasion at different dose strengths. In addition, one group in Part A will investigate the effect of food on the safety, tolerability and concentration of RXC007 in the blood by taking a single dose of RXC007 following an overnight fast and then following a high fat breakfast. Part A will consist of 6 planned groups of 6 participants: each group investigating a different dose strength starting at the lowest dose and gradually increasing in each group. If required and determined as necessary following dose escalation data review, Part A may enrol up to a maximum of 4 additional cohorts with a maximum of 8 participants within each cohort.
Part A of the study will consist of a screening visit (between 28 and 2 days prior to first dose), a treatment period (consisting of a maximum of 5 days with 4 overnight stays) and a post-study follow-up visit on Day 15. For the food effect cohort, an additional treatment period (consisting of a maximum of 5 days with 4 overnight stays) will be undertaken following an approximately 4-week washout period with a second follow-up visit to be conducted on Day 15 following the second treatment period.
The purpose of Part B is to evaluate the safety, tolerability and concentration of RXC007 in the blood when it is given as a single dose once a day for a period of 14 days at different dose strengths. Part B will consist of up to 2 planned groups of 6 participants; each group investigating a different dose strength based on the data generated during Part A of the study. If required and determined as necessary following dose escalation data review, Part B may enrol up to a maximum of 4 additional cohorts with a maximum of 8 participants within each cohort.
Part B of the study will consist of a screening visit (between 28 and 2 days prior to first dose), a treatment period (consisting of a maximum of 18 days with 17 overnight stays) and a post-study follow-up visit on Day 28.
Within each cohort in Part A and Part B, 4 participants will receive RXC007 with the remaining 2 participants receiving a matching placebo. Each cohort will follow a dose leader schedule, whereby 2 participants (1 active, 1 placebo) will be dosed a minimum of 24 hours prior to the remaining 4 participants in the cohort. Between each cohort, safety and PK data up to the 72-hour post-last dose time point for Part A and up to Day 17 in Part B will be evaluated by a Dose Escalation Review Committee (DERC) to determine whether it is appropriate to dose escalate into the next cohort. If required, i.e., the safety or pharmacokinetics (PK) data indicates, dose modifications may be made in order to select an intermediate/lower dose. In addition, modifications may be made following both treatment periods for the food effect cohort in Part A to dose all remaining cohorts in Part A and Part B in a fed state (with a standardised breakfast) and in Part B, the dose regime may be modified in terms of frequency to increase dosing from once per day to multiple times per day. In addition, decisions may be made that the proposed length of the in-house treatment period in both Part A \& Part B should be reduced by one day (from Day 4 to Day 3 in Part A and from Day 17 to Day 16 in Part B).
The purpose of Part C is to evaluate the safety, tolerability and effect of RXC007 on the concentration of rosuvastatin and metformin in the blood to determine as to whether RXC007 affects the activity of the processes by which certain types of drugs are broken down (metabolised) in the body and therefore, whether RXC007 has the potential to interact with other drugs, affecting their desired effect in the body i.e., evaluating the drug-drug interaction potential of RXC007.
Part C will consist of 2 groups of 12 participants; Group 1 evaluating the drug-drug interactions of RXC007 and rosuvastatin (at a dose strength of 10 mg in an oral tablet formulation) and Group 2 evaluating the drug-drug interactions of RXC007 and metformin (at a dose strength of 500 mg in an oral tablet formulation). The dose strength of RXC007 to be evaluated will be selected based on review of the data generated in Part B of the study.
Part C of the study will consist of a screening visit (between 28 and 2 days prior to first dose), a treatment period (consisting of either a maximum of 14 days with 13 overnight stays for Group 1 or a maximum of 11 days with 10 overnight stays for Group 2) and a post-study follow-up visit approximately 14 days following the last dose of RXC007 with rosuvastatin or metformin (either Day 23 or Day 21 respectively for Group 1 and Group 2).
- Conditions
- Fibrosis, Inflammation, Idiopathic Pulmonary Fibrosis, Non-alcoholic Steatohepatitis, Liver Diseases, Kidney Diseases
- Being tested
- RXC007, RXC007 Matching Placebo
- Medical subject headings
- Fibrosis, Inflammation, Idiopathic Pulmonary Fibrosis, Non-alcoholic Fatty Liver Disease, Liver Diseases, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RXC007Drug
RXC007 will be administered in the form of oral capsules at selected doses starting at 2 mg to 4 of the 6 participants within each cohort in Part A and Part B. For Part A, dosing frequency is one single dose on one occasion and for Part B, dosing frequency is single doses once daily for 14 days. If required, following dose escalation data review, dosing frequency and duration may be modified in Part B.
All participants in Part C (24) will receive active RXC007 in the form of oral capsules as single doses.
RXC007 Matching PlaceboDrug
The matching placebo for RXC007 will be administered in the form of oral capsules matched to the number of active RXC007 capsules at each dose level to 2 of the 6 participants within each cohort in Part A and Part B. For Part A, dosing frequency is one placebo dose on one occasion and for Part B, dosing frequency is single placebo doses once daily for 14 days. If required, following dose escalation data review, dosing frequency and duration may be modified in Part B.
There is no placebo intervention for Part C of the study.
| Study group | Role | What they receive |
|---|---|---|
| Part A SAD - Cohort 1 | Experimental | This is the first treatment arm in Part A (Single Ascending Dose) of the study. 4 participants will be randomised to receive 2 mg of RXC007 on one occasion on Day 1. The remaining 2 participants will receive matching placebo. Receives: Drug: RXC007; Drug: RXC007 Matching Placebo |
| Part A SAD - Cohort 2 | Experimental | This is the second treatment arm in Part A (Single Ascending Dose) of the study. 4 participants will be randomised to receive a selected dose of RXC007 (following Cohort 1 Dose Escalation Data Review) on one occasion on Day 1. The remaining 2 participants will receive matching placebo. Receives: Drug: RXC007; Drug: RXC007 Matching Placebo |
| Part A SAD - Cohort 3 | Experimental | This is the third treatment arm in Part A (Single Ascending Dose) of the study. 4 participants will be randomised to receive a selected dose of RXC007 (following Dose Escalation Data Review of previous cohorts data) on one occasion on Day 1. The remaining 2 participants will receive matching placebo. Receives: Drug: RXC007; Drug: RXC007 Matching Placebo |
| Part A SAD - Cohort 4 | Experimental | This is the fourth treatment arm in Part A (Single Ascending Dose) of the study. 4 participants will be randomised to receive a selected dose of RXC007 (following Dose Escalation Data Review of previous cohorts data) on one occasion on Day 1. The remaining 2 participants will receive matching placebo. Receives: Drug: RXC007; Drug: RXC007 Matching Placebo |
| Part A SAD - Cohort 5 | Experimental | This is the fifth treatment arm in Part A (Single Ascending Dose) of the study. 4 participants will be randomised to receive a selected dose of RXC007 (following Dose Escalation Data Review of previous cohorts data) on one occasion on Day 1. The remaining 2 participants will receive matching placebo. Receives: Drug: RXC007; Drug: RXC007 Matching Placebo |
| Part A SAD - Cohort 6 | Experimental | This is the sixth treatment arm in Part A (Single Ascending Dose) of the study. 4 participants will be randomised to receive a selected dose of RXC007 (following Dose Escalation Data Review of previous cohorts data) on one occasion on Day 1. The remaining 2 participants will receive matching placebo. Receives: Drug: RXC007; Drug: RXC007 Matching Placebo |
| Part A SAD - Optional Cohort 7 | Experimental | This is an optional seventh treatment arm in Part A (Single Ascending Dose) of the study. If deemed as necessary following Dose Escalation Data Review of previous cohorts data, up to 8 participants may be enrolled into this optional cohort. If enrolled, up to 6 participants will be randomised to receive a selected dose of RXC007 (following Dose Escalation Data Review of previous cohorts data) on one occasion on Day 1. The remaining 2 participants will receive matching placebo. Receives: Drug: RXC007; Drug: RXC007 Matching Placebo |
| Part A SAD - Optional Cohort 8 | Experimental | This is an optional eighth treatment arm in Part A (Single Ascending Dose) of the study. If deemed as necessary following Dose Escalation Data Review of previous cohorts data, up to 8 participants may be enrolled into this optional cohort. If enrolled, up to 6 participants will be randomised to receive a selected dose of RXC007 (following Dose Escalation Data Review of previous cohorts data) on one occasion on Day 1. The remaining 2 participants will receive matching placebo. Receives: Drug: RXC007; Drug: RXC007 Matching Placebo |
| Part B MAD - Cohort 1 | Experimental | This is the first treatment arm in Part B (Multiple Ascending Dose) of the study. 4 participants will be randomised to receive a selected dose of RXC007 (following Dose Escalation Data Review of SAD cohort data) once daily for 14 days. The remaining 2 participants will receive matching placebo. Receives: Drug: RXC007; Drug: RXC007 Matching Placebo |
| Part B MAD - Cohort 2 | Experimental | This is the second treatment arm in Part B (Multiple Ascending Dose) of the study. 4 participants will be randomised to receive a selected dose of RXC007 (following Dose Escalation Data Review of SAD and previous MAD cohort data) once daily for 14 days. The remaining 2 participants will receive matching placebo. Receives: Drug: RXC007; Drug: RXC007 Matching Placebo |
| Part B MAD - Optional Cohort 3 | Experimental | This is an optional third treatment arm in Part B (Multiple Ascending Dose) of the study. If deemed as necessary following Dose Escalation Data Review of previous cohorts data, up to 8 participants may be enrolled into this optional cohort. If enrolled, up to 6 participants will be randomised to receive a selected dose of RXC007 (following Dose Escalation Data Review of previous cohorts data) once daily for 14 days. The remaining 2 participants will receive matching placebo. Receives: Drug: RXC007; Drug: RXC007 Matching Placebo |
| Part B MAD - Optional Cohort 4 | Experimental | This is an optional fourth treatment arm in Part B (Multiple Ascending Dose) of the study. If deemed as necessary following Dose Escalation Data Review of previous cohorts data, up to 8 participants may be enrolled into this optional cohort. If enrolled, up to 6 participants will be randomised to receive a selected dose of RXC007 (following Dose Escalation Data Review of previous cohorts data) once daily for 14 days. The remaining 2 participants will receive matching placebo. Receives: Drug: RXC007; Drug: RXC007 Matching Placebo |
| Part A SAD - Optional Cohort 9 | Experimental | This is an optional ninth treatment arm in Part A (Single Ascending Dose) of the study. If deemed as necessary following Dose Escalation Data Review of previous cohorts data, up to 8 participants may be enrolled into this optional cohort. If enrolled, up to 6 participants will be randomised to receive a selected dose of RXC007 (following Dose Escalation Data Review of previous cohorts data) on one occasion on Day 1. The remaining 2 participants will receive matching placebo. Receives: Drug: RXC007; Drug: RXC007 Matching Placebo |
| Part A SAD - Optional Cohort 10 | Experimental | This is an optional tenth treatment arm in Part A (Single Ascending Dose) of the study. If deemed as necessary following Dose Escalation Data Review of previous cohorts data, up to 8 participants may be enrolled into this optional cohort. If enrolled, up to 6 participants will be randomised to receive a selected dose of RXC007 (following Dose Escalation Data Review of previous cohorts data) on one occasion on Day 1. The remaining 2 participants will receive matching placebo. Receives: Drug: RXC007; Drug: RXC007 Matching Placebo |
| Part B MAD - Optional Cohort 5 | Experimental | This is an optional fifth treatment arm in Part B (Multiple Ascending Dose) of the study. If deemed as necessary following Dose Escalation Data Review of previous cohorts data, up to 8 participants may be enrolled into this optional cohort. If enrolled, up to 6 participants will be randomised to receive a selected dose of RXC007 (following Dose Escalation Data Review of previous cohorts data) once daily for 14 days. The remaining 2 participants will receive matching placebo. Receives: Drug: RXC007; Drug: RXC007 Matching Placebo |
| Part B MAD - Optional Cohort 6 | Experimental | This is an optional sixth treatment arm in Part B (Multiple Ascending Dose) of the study. If deemed as necessary following Dose Escalation Data Review of previous cohorts data, up to 8 participants may be enrolled into this optional cohort. If enrolled, up to 6 participants will be randomised to receive a selected dose of RXC007 (following Dose Escalation Data Review of previous cohorts data) once daily for 14 days. The remaining 2 participants will receive matching placebo. Receives: Drug: RXC007; Drug: RXC007 Matching Placebo |
| Part C DDI - Cohort 1 Rosuvastatin | Experimental | This is the first treatment arm in Part C (Drug-Drug Interaction) of the study. All participants within the cohort (12 participants) will to receive a selected dose of RXC007 (following Dose Escalation Data Review from Part A and Part B) and 10 mg rosuvastatin as follows: single dose of rosuvastatin (10 milligrams) on Day 1 followed by three single doses of RXC007 on Day 6, Day 7 \& Day 8 before taking a single dose of both RXC007 and rosuvastatin together on Day 9. Receives: Drug: RXC007 |
| Part C DDI - Cohort 2 Metformin | Experimental | This is the second treatment arm in Part C (Drug-Drug Interaction) of the study. All participants within the cohort (12 participants) will to receive a selected dose of RXC007 (following Dose Escalation Data Review from Part A and Part B) and 500 mg metformin as follows: single dose of metformin (500 milligrams) on Day 1 followed by three single doses of RXC007 on Day 4, Day 5 \& Day 6 before taking a single dose of both RXC007 and metformin together on Day 7. Receives: Drug: RXC007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Events
This primary endpoint relates to the number of participants who report a treatment emergent adverse event (TEAEs) across all study parts.
Measured: Collection of TEAEs occurs through ad hoc reporting from the participants from the point of first dose administration (Day 1 in each part) through to study completion (up to 6 weeks for Part A & up to 8 weeks for Part B & C).
Number of participants who report a change from normal range values for laboratory safety parameters (serum biochemistry, serum haematology or urinalysis) from first dose on Day 1 to post-study follow up visit.
This primary endpoint will report the number of participants within each cohort of Part A, Part B \& Part C of the study who record a value which is deemed as outside of the normal range (regardless of clinical significance) for any of the serum biochemistry, serum haematology or urinalysis parameters as defined in the study protocol following first dose administration on Day 1 up to completion of the post-study visit.
Measured: Part A: From Day 1 to post-study follow up visit (up to 6 weeks) & Part B/C: From Day 1 to post-study follow up visit (up to 8 weeks)
Number of participants who report a change from normal range values for vital signs parameters (blood pressure, pulse rate, respiration rate, oral body temperature) from first dose on Day 1 to post-study follow up visit.
This primary endpoint will report the number of participants within each cohort of Part A, Part B \& Part C of the study who record a value which is deemed as outside of the normal range (regardless of clinical significance) for any of the vital signs parameters (systolic/diastolic blood pressure, pulse rate, respiration rate, oral body temperature) as defined in the study protocol following first dose administration on Day 1 up to completion of the post-study visit.
Measured: Part A: From Day 1 to post-study follow up visit (up to 6 weeks) & Part B/C: From Day 1 to post-study follow up visit (up to 8 weeks)
Number of participants who report a change from normal range values for any of the associated 12-Lead ECG parameters (heart rate, PR interval, QRS width, QT interval and QTcF interval) from first dose on Day 1 to post-study follow up visit.
This primary endpoint will report the number of participants within each cohort of Part A, Part B \& Part C of the study who record a value which is deemed as outside of the normal range (regardless of clinical significance) for any of the 12-Lead ECG parameters (heart rate, PR interval, QRS width, QT interval and QTcF interval) as defined in the study protocol following first dose administration on Day 1 up to completion of the post-study visit.
Measured: Part A: From Day 1 to post-study follow up visit (up to 6 weeks) & Part B/C: From Day 1 to post-study follow up visit (up to 8 weeks)
Secondary outcomes (30)
Pharmacokinetic Parameters - Part A - Maximum observed concentration (Cmax)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the maximum observed concentration (Cmax) of RXC007 in plasma for Part A cohorts.
Measured: Plasma samples for Cmax evaluation of RXC007 in Part A: Day 1 pre-dose, 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr, 48 hr, 72 hr post-dose & post-study follow up (up to 6 weeks for Part A).
Pharmacokinetic Parameters - Part A - Time to maximum observed concentration (Tmax)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the time to maximum observed concentration (Tmax) of RXC007 in plasma for Part A cohorts.
Measured: Plasma samples for Tmax evaluation of RXC007 in Part A: Day 1 pre-dose, 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr, 48 hr, 72 hr post-dose & post-study follow up (up to 6 weeks for Part A).
Pharmacokinetic Parameters - Part A - Elimination rate constant (λz)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the elimination rate constant (λz) of RXC007 in plasma for Part A cohorts.
Measured: Plasma samples for λz evaluation of RXC007 in Part A: Day 1 pre-dose, 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr, 48 hr, 72 hr post-dose & post-study follow up (up to 6 weeks for Part A).
Pharmacokinetic Parameters - Part A - Terminal elimination half-life (t1/2)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the terminal elimination half-life (t1/2) of RXC007 in plasma for Part A cohorts.
Measured: Plasma samples for t1/2 evaluation of RXC007 in Part A: Day 1 pre-dose, 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr, 48 hr, 72 hr post-dose & post-study follow up (up to 6 weeks for Part A).
Pharmacokinetic Parameters - Part A - Area under the concentration-time curve (AUC) from the time of dosing to the time of the last measurable concentration (AUC0-t)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the area under the concentration-time curve (AUC) from the time of dosing to the time of the last measurable concentration (AUC0-t) of RXC007 in plasma for Part A cohorts.
Measured: Plasma samples for AUC0-t evaluation of RXC007 in Part A: Day 1 pre-dose, 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr, 48 hr, 72 hr post-dose & post-study follow up (up to 6 weeks for Part A).
Pharmacokinetic Parameters - Part A - Area under the concentration-time curve (AUC) extrapolated to infinity (AUC0-inf)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the area under the concentration-time curve (AUC) extrapolated to infinity (AUC0-inf) of RXC007 in plasma for Part A cohorts.
Measured: Plasma samples for AUC0-inf evaluation of RXC007 in Part A: Day 1 pre-dose, 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr, 48 hr, 72 hr post-dose & post-study follow up (up to 6 weeks for Part A).
Pharmacokinetic Parameters - Part A - Residual Area (AUC%extrapolated)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the residual area (AUC%extrapolated) of RXC007 in plasma for Part A cohorts.
Measured: Plasma samples for AUC%extrapolated evaluation of RXC007 in Part A: Day 1 pre-dose, 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr, 48 hr, 72 hr post-dose & post-study follow up (up to 6 weeks for Part A).
Pharmacokinetic Parameters - Part A - Total apparent clearance following extravascular administration (CL/F)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the total apparent clearance following extravascular administration (CL/F) of RXC007 in plasma for Part A cohorts.
Measured: Plasma samples for CL/F evaluation of RXC007 in Part A: Day 1 pre-dose, 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr, 48 hr, 72 hr post-dose & post-study follow up (up to 6 weeks for Part A).
Pharmacokinetic Parameters - Part A - Apparent volume of distribution following extravascular administration (Vz/F)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the apparent volume of distribution following extravascular administration (Vz/F) of RXC007 in plasma for Part A cohorts.
Measured: Plasma samples for Vz/F evaluation of RXC007 in Part A: Day 1 pre-dose, 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr, 48 hr, 72 hr post-dose & post-study follow up (up to 6 weeks for Part A).
Pharmacokinetic Parameters - Part B - Maximum observed concentration (Cmax)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the maximum observed concentration (Cmax) of RXC007 in plasma for Part B cohorts.
Measured: Plasma samples for Cmax evaluation of RXC007 in Part B: Day 1 & 14: 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr post-dose, Day 7, Day 16: 48 hr post-Day 14 dose & Day 17: 72 hr post-Day 14 dose (up to 8 weeks for Part B).
Pharmacokinetic Parameters - Part B - Time to maximum observed concentration (Tmax)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the time to maximum observed concentration (Tmax) of RXC007 in plasma for Part B cohorts.
Measured: Plasma samples for Tmax evaluation of RXC007 in Part B: Day 1 & 14: 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr post-dose, Day 7, Day 16: 48 hr post-Day 14 dose & Day 17: 72 hr post-Day 14 dose (up to 8 weeks for Part B).
Pharmacokinetic Parameters - Part B - Elimination rate constant (λz)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the elimination rate constant (λz) of RXC007 in plasma for Part B cohorts.
Measured: Plasma samples for λz evaluation of RXC007 in Part B: Day 1 & 14: 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr post-dose, Day 7, Day 16: 48 hr post-Day 14 dose & Day 17: 72 hr post-Day 14 dose (up to 8 weeks for Part B).
Pharmacokinetic Parameters - Part B - Terminal elimination half-life (t1/2)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the terminal elimination half-life (t1/2) of RXC007 in plasma for Part B cohorts.
Measured: Plasma samples for t1/2 evaluation of RXC007 in Part B: Day 1 & 14: 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr post-dose, Day 7, Day 16: 48 hr post-Day 14 dose & Day 17: 72 hr post-Day 14 dose (up to 8 weeks for Part B).
Pharmacokinetic Parameters - Part B - Area under the concentration-time curve (AUC) from 0 to τ, where τ is the dosing interval (0 - 24 h) (AUC0-τ)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the area under the concentration-time curve (AUC) from 0 to τ, where τ is the dosing interval (0 - 24 h) (AUC0-τ) of RXC007 in plasma for Part B cohorts.
Measured: Plasma samples for AUC0-τ evaluation of RXC007 in Part B: Day 1 & 14: 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr post-dose, Day 7, Day 16: 48 hr post-Day 14 dose & Day 17: 72 hr post-Day 14 dose (up to 8 weeks for Part B).
Pharmacokinetic Parameters - Part B - Area under the concentration-time curve (AUC) from the time of dosing to the time of the last measurable concentration (AUC0-t)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the area under the concentration-time curve (AUC) from the time of dosing to the time of the last measurable concentration (AUC0-t) of RXC007 in plasma for Part B cohorts.
Measured: Plasma samples for AUC0-t evaluation of RXC007 in Part B: Day 1 & 14: 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr post-dose, Day 7, Day 16: 48 hr post-Day 14 dose & Day 17: 72 hr post-Day 14 dose (up to 8 weeks for Part B).
Pharmacokinetic Parameters - Part B - Area under the concentration-time curve (AUC) extrapolated to infinity (AUC0-inf)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the area under the concentration-time curve (AUC) extrapolated to infinity (AUC0-inf) of RXC007 in plasma for Part B cohorts.
Measured: Plasma samples for AUC0-inf evaluation of RXC007 in Part B: Day 1 & 14: 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr post-dose, Day 7, Day 16: 48 hr post-Day 14 dose & Day 17: 72 hr post-Day 14 dose (up to 8 weeks for Part B).
Pharmacokinetic Parameters - Part B - Residual area (AUC%extrapolated)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the residual area (AUC%extrapolated) of RXC007 in plasma for Part B cohorts.
Measured: Plasma samples for AUC%extrapolated evaluation of RXC007 in Part B: Day 1 & 14: 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr post-dose, Day 7, Day 16: 48 hr post-Day 14 dose & Day 17: 72 hr post-Day 14 dose (up to 8 weeks for Part B).
Pharmacokinetic Parameters - Part B - Accumulation ratio calculated from Cmax (ARCmax)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the accumulation ratio calculated from Cmax (ARCmax) of RXC007 in plasma for Part B cohorts.
Measured: Plasma samples for ARCmax evaluation of RXC007 in Part B: Day 1 & 14: 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr post-dose, Day 7, Day 16: 48 hr post-Day 14 dose & Day 17: 72 hr post-Day 14 dose (up to 8 weeks for Part B).
Pharmacokinetic Parameters - Part B - Accumulation ratio calculated from AUC (ARAUC)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the accumulation ratio calculated from AUC (ARAUC) of RXC007 in plasma for Part B cohorts.
Measured: Plasma samples for ARAUC evaluation of RXC007 in Part B: Day 1 & 14: 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr post-dose, Day 7, Day 16: 48 hr post-Day 14 dose & Day 17: 72 hr post-Day 14 dose (up to 8 weeks for Part B).
Pharmacokinetic Parameters - Part B - Total apparent clearance following extravascular administration (CL/F)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the total apparent clearance following extravascular administration (CL/F) of RXC007 in plasma for Part B cohorts.
Measured: Plasma samples for CL/F evaluation of RXC007 in Part B: Day 1 & 14: 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr post-dose, Day 7, Day 16: 48 hr post-Day 14 dose & Day 17: 72 hr post-Day 14 dose (up to 8 weeks for Part B).
Pharmacokinetic Parameters - Part B - Apparent volume of distribution following extravascular administration (Vz/F)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the apparent volume of distribution following extravascular administration (Vz/F) of RXC007 in plasma for Part B cohorts.
Measured: Plasma samples for Vz/F evaluation of RXC007 in Part B: Day 1 & 14: 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr post-dose, Day 7, Day 16: 48 hr post-Day 14 dose & Day 17: 72 hr post-Day 14 dose (up to 8 weeks for Part B).
Pharmacokinetic Parameters - Part C - Maximum observed concentration (Cmax)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007, Rosuvastatin and Metformin. This endpoint will report the summary of derived pharmacokinetic parameters for the maximum observed concentration (Cmax) of RXC007, rosuvastatin and metformin in plasma for Part C cohorts.
Measured: Plasma samples for Cmax evaluation of in Part C: Maximum of 34 samples in Cohort 1 from Day 1 pre-dose to Day 13 and maximum of 33 samples in Cohort 2 from Day 1 pre-dose to Day 10
Pharmacokinetic Parameters - Part C - Time to maximum observed concentration (Tmax)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007, Rosuvastatin and Metformin. This endpoint will report the summary of derived pharmacokinetic parameters for the time to maximum observed concentration (Tmax) of RXC007, rosuvastatin and metformin in plasma for Part C cohorts.
Measured: Plasma samples for Tmax evaluation of in Part C: Maximum of 34 samples in Cohort 1 from Day 1 pre-dose to Day 13 and maximum of 33 samples in Cohort 2 from Day 1 pre-dose to Day 10
Pharmacokinetic Parameters - Part C - Elimination rate constant (λz)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007, Rosuvastatin and Metformin. This endpoint will report the summary of derived pharmacokinetic parameters for the time to elimination rate constant (λz) of RXC007, rosuvastatin and metformin in plasma for Part C cohorts.
Measured: Plasma samples for λz evaluation of in Part C: Maximum of 34 samples in Cohort 1 from Day 1 pre-dose to Day 13 and maximum of 33 samples in Cohort 2 from Day 1 pre-dose to Day 10
Pharmacokinetic Parameters - Part C - Terminal elimination half-life (t1/2)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007, Rosuvastatin and Metformin. This endpoint will report the summary of derived pharmacokinetic parameters for the time to terminal elimination half-life (t1/2) of RXC007, rosuvastatin and metformin in plasma for Part C cohorts.
Measured: Plasma samples for t1/2 evaluation of in Part C: Maximum of 34 samples in Cohort 1 from Day 1 pre-dose to Day 13 and maximum of 33 samples in Cohort 2 from Day 1 pre-dose to Day 10
Pharmacokinetic Parameters - Part C - Area under the concentration-time curve (AUC) from the time of dosing to the time of the last measurable concentration (AUC0-t)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007, Rosuvastatin and Metformin. This endpoint will report the summary of derived pharmacokinetic parameters for the area under the concentration-time curve (AUC) from the time of dosing to the time of the last measurable concentration (AUC0-t) of RXC007, rosuvastatin and metformin in plasma for Part C cohorts.
Measured: Plasma samples for AUC0-t evaluation of in Part C: Maximum of 34 samples in Cohort 1 from Day 1 pre-dose to Day 13 and maximum of 33 samples in Cohort 2 from Day 1 pre-dose to Day 10
Pharmacokinetic Parameters - Part C - Area under the concentration-time curve (AUC) extrapolated to infinity (AUC0-inf)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007, Rosuvastatin and Metformin. This endpoint will report the summary of derived pharmacokinetic parameters for the area under the concentration-time curve (AUC) extrapolated to infinity (AUC0-inf) of RXC007, rosuvastatin and metformin in plasma for Part C cohorts.
Measured: Plasma samples for AUC0-inf evaluation of in Part C: Maximum of 34 samples in Cohort 1 from Day 1 pre-dose to Day 13 and maximum of 33 samples in Cohort 2 from Day 1 pre-dose to Day 10
Pharmacokinetic Parameters - Part C - Residual area (AUC%extrapolated)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007, Rosuvastatin and Metformin. This endpoint will report the summary of derived pharmacokinetic parameters for the residual area (AUC%extrapolated) of RXC007, rosuvastatin and metformin in plasma for Part C cohorts.
Measured: Plasma samples for AUC%extrapolated evaluation of in Part C: Maximum of 34 samples in Cohort 1 from Day 1 pre-dose to Day 13 and maximum of 33 samples in Cohort 2 from Day 1 pre-dose to Day 10
Pharmacokinetic Parameters - Part C - Total apparent clearance following extravascular administration (CL/F)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007, Rosuvastatin and Metformin. This endpoint will report the summary of derived pharmacokinetic parameters for the total apparent clearance following extravascular administration (CL/F) of RXC007, rosuvastatin and metformin in plasma for Part C cohorts.
Measured: Plasma samples for CL/F evaluation of in Part C: Maximum of 34 samples in Cohort 1 from Day 1 pre-dose to Day 13 and maximum of 33 samples in Cohort 2 from Day 1 pre-dose to Day 10
Pharmacokinetic Parameters - Part C - Apparent volume of distribution following extravascular administration (Vz/F)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007, Rosuvastatin and Metformin. This endpoint will report the summary of derived pharmacokinetic parameters for the apparent volume of distribution following extravascular administration (Vz/F) of RXC007, rosuvastatin and metformin in plasma for Part C cohorts.
Measured: Plasma samples for Vz/F evaluation of in Part C: Maximum of 34 samples in Cohort 1 from Day 1 pre-dose to Day 13 and maximum of 33 samples in Cohort 2 from Day 1 pre-dose to Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start13 May 2021
- Primary completion8 Mar 2023
- Study completion8 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This study is a first-in-human, single ascending (SAD) and multiple ascending dose (MAD) study, including the evaluation of drug-drug interactions. Each cohort will adopt a dose leader design with 2 participants being dosed on the first dosing day of each cohort. Of these 2, 1 will be on active drug and 1 on placebo. The remainder of the cohort will be dosed at least 24 h later pending an acceptable safety profile in the dose-leader group and will contain at least 1 additional placebo participant. In both Part A (SAD) and Part B (MAD), sequential cohorts will be exposed to increasing doses of RXC007. Prior to dose escalation between cohorts, safety and PK data from the previous cohort will be reviewed by the Dose Escalation Review Committee (DERC) to determine whether it is appropriate to proceed to the next cohort/dose level.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Redx Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Responsible party
- Sponsor
- Investigators
- Annelize Koch, Principal investigator, Simbec-Orion Clinical Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931147
- Sponsor's protocol ID
- RXC007/0001
- Status last verified
- Nov 2023
- First submitted
- 4 Jun 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this stage, it is not planned that any IPD information will be shared with other researchers outside of the Sponsor and Clinical Research Organisation undertaking the conduct of this study.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, SAD/MAD First-in-human, Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RXC007 Including Evaluation of Drug-Drug Interaction and Food Effect in Male Participants
- ClinicalTrials.gov ID
- NCT04931147
- Acronym / sponsor ID
- RXC007/0001
- Conditions
- Fibrosis, Inflammation, Idiopathic Pulmonary Fibrosis, Non-alcoholic Steatohepatitis, Liver Diseases, Kidney Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Redx Pharma LtdIndustry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Study start
- 13 May 2021 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of RXC007.
Detailed description
The study will be split into 3 parts: Part A, Part B \& Part C.
The overall study will enrol up to 136 healthy males; maximum of 68 in Part A, maximum of 44 in Part B and maximum of 24 in Part C.
The purpose of Part A is to evaluate the safety, tolerability and concentration of RXC007 in the blood when it is given as a single dose on one occasion at different dose strengths. In addition, one group in Part A will investigate the effect of food on the safety, tolerability and concentration of RXC007 in the blood by taking a single dose of RXC007 following an overnight fast and then following a high fat breakfast. Part A will consist of 6 planned groups of 6 participants: each group investigating a different dose strength starting at the lowest dose and gradually increasing in each group. If required and determined as necessary following dose escalation data review, Part A may enrol up to a maximum of 4 additional cohorts with a maximum of 8 participants within each cohort.
Part A of the study will consist of a screening visit (between 28 and 2 days prior to first dose), a treatment period (consisting of a maximum of 5 days with 4 overnight stays) and a post-study follow-up visit on Day 15. For the food effect cohort, an additional treatment period (consisting of a maximum of 5 days with 4 overnight stays) will be undertaken following an approximately 4-week washout period with a second follow-up visit to be conducted on Day 15 following the second treatment period.
The purpose of Part B is to evaluate the safety, tolerability and concentration of RXC007 in the blood when it is given as a single dose once a day for a period of 14 days at different dose strengths. Part B will consist of up to 2 planned groups of 6 participants; each group investigating a different dose strength based on the data generated during Part A of the study. If required and determined as necessary following dose escalation data review, Part B may enrol up to a maximum of 4 additional cohorts with a maximum of 8 participants within each cohort.
Part B of the study will consist of a screening visit (between 28 and 2 days prior to first dose), a treatment period (consisting of a maximum of 18 days with 17 overnight stays) and a post-study follow-up visit on Day 28.
Within each cohort in Part A and Part B, 4 participants will receive RXC007 with the remaining 2 participants receiving a matching placebo. Each cohort will follow a dose leader schedule, whereby 2 participants (1 active, 1 placebo) will be dosed a minimum of 24 hours prior to the remaining 4 participants in the cohort. Between each cohort, safety and PK data up to the 72-hour post-last dose time point for Part A and up to Day 17 in Part B will be evaluated by a Dose Escalation Review Committee (DERC) to determine whether it is appropriate to dose escalate into the next cohort. If required, i.e., the safety or pharmacokinetics (PK) data indicates, dose modifications may be made in order to select an intermediate/lower dose. In addition, modifications may be made following both treatment periods for the food effect cohort in Part A to dose all remaining cohorts in Part A and Part B in a fed state (with a standardised breakfast) and in Part B, the dose regime may be modified in terms of frequency to increase dosing from once per day to multiple times per day. In addition, decisions may be made that the proposed length of the in-house treatment period in both Part A \& Part B should be reduced by one day (from Day 4 to Day 3 in Part A and from Day 17 to Day 16 in Part B).
The purpose of Part C is to evaluate the safety, tolerability and effect of RXC007 on the concentration of rosuvastatin and metformin in the blood to determine as to whether RXC007 affects the activity of the processes by which certain types of drugs are broken down (metabolised) in the body and therefore, whether RXC007 has the potential to interact with other drugs, affecting their desired effect in the body i.e., evaluating the drug-drug interaction potential of RXC007.
Part C will consist of 2 groups of 12 participants; Group 1 evaluating the drug-drug interactions of RXC007 and rosuvastatin (at a dose strength of 10 mg in an oral tablet formulation) and Group 2 evaluating the drug-drug interactions of RXC007 and metformin (at a dose strength of 500 mg in an oral tablet formulation). The dose strength of RXC007 to be evaluated will be selected based on review of the data generated in Part B of the study.
Part C of the study will consist of a screening visit (between 28 and 2 days prior to first dose), a treatment period (consisting of either a maximum of 14 days with 13 overnight stays for Group 1 or a maximum of 11 days with 10 overnight stays for Group 2) and a post-study follow-up visit approximately 14 days following the last dose of RXC007 with rosuvastatin or metformin (either Day 23 or Day 21 respectively for Group 1 and Group 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 18
- Model description
- This study is a first-in-human, single ascending (SAD) and multiple ascending dose (MAD) study, including the evaluation of drug-drug interactions. Each cohort will adopt a dose leader design with 2 participants being dosed on the first dosing day of each cohort. Of these 2, 1 will be on active drug and 1 on placebo. The remainder of the cohort will be dosed at least 24 h later pending an acceptable safety profile in the dose-leader group and will contain at least 1 additional placebo participant. In both Part A (SAD) and Part B (MAD), sequential cohorts will be exposed to increasing doses of RXC007. Prior to dose escalation between cohorts, safety and PK data from the previous cohort will be reviewed by the Dose Escalation Review Committee (DERC) to determine whether it is appropriate to proceed to the next cohort/dose level.
| Arm | Type | Receives |
|---|---|---|
| Part A SAD - Cohort 1 | Experimental | Drug: RXC007, Drug: RXC007 Matching PlaceboThis is the first treatment arm in Part A (Single Ascending Dose) of the study. 4 participants will be randomised to receive 2 mg of RXC007 on one occasion on Day 1. The remaining 2 participants will receive matching placebo. |
| Part A SAD - Cohort 2 | Experimental | Drug: RXC007, Drug: RXC007 Matching PlaceboThis is the second treatment arm in Part A (Single Ascending Dose) of the study. 4 participants will be randomised to receive a selected dose of RXC007 (following Cohort 1 Dose Escalation Data Review) on one occasion on Day 1. The remaining 2 participants will receive matching placebo. |
| Part A SAD - Cohort 3 | Experimental | Drug: RXC007, Drug: RXC007 Matching PlaceboThis is the third treatment arm in Part A (Single Ascending Dose) of the study. 4 participants will be randomised to receive a selected dose of RXC007 (following Dose Escalation Data Review of previous cohorts data) on one occasion on Day 1. The remaining 2 participants will receive matching placebo. |
| Part A SAD - Cohort 4 | Experimental | Drug: RXC007, Drug: RXC007 Matching PlaceboThis is the fourth treatment arm in Part A (Single Ascending Dose) of the study. 4 participants will be randomised to receive a selected dose of RXC007 (following Dose Escalation Data Review of previous cohorts data) on one occasion on Day 1. The remaining 2 participants will receive matching placebo. |
| Part A SAD - Cohort 5 | Experimental | Drug: RXC007, Drug: RXC007 Matching PlaceboThis is the fifth treatment arm in Part A (Single Ascending Dose) of the study. 4 participants will be randomised to receive a selected dose of RXC007 (following Dose Escalation Data Review of previous cohorts data) on one occasion on Day 1. The remaining 2 participants will receive matching placebo. |
| Part A SAD - Cohort 6 | Experimental | Drug: RXC007, Drug: RXC007 Matching PlaceboThis is the sixth treatment arm in Part A (Single Ascending Dose) of the study. 4 participants will be randomised to receive a selected dose of RXC007 (following Dose Escalation Data Review of previous cohorts data) on one occasion on Day 1. The remaining 2 participants will receive matching placebo. |
| Part A SAD - Optional Cohort 7 | Experimental | Drug: RXC007, Drug: RXC007 Matching PlaceboThis is an optional seventh treatment arm in Part A (Single Ascending Dose) of the study. If deemed as necessary following Dose Escalation Data Review of previous cohorts data, up to 8 participants may be enrolled into this optional cohort. If enrolled, up to 6 participants will be randomised to receive a selected dose of RXC007 (following Dose Escalation Data Review of previous cohorts data) on one occasion on Day 1. The remaining 2 participants will receive matching placebo. |
| Part A SAD - Optional Cohort 8 | Experimental | Drug: RXC007, Drug: RXC007 Matching PlaceboThis is an optional eighth treatment arm in Part A (Single Ascending Dose) of the study. If deemed as necessary following Dose Escalation Data Review of previous cohorts data, up to 8 participants may be enrolled into this optional cohort. If enrolled, up to 6 participants will be randomised to receive a selected dose of RXC007 (following Dose Escalation Data Review of previous cohorts data) on one occasion on Day 1. The remaining 2 participants will receive matching placebo. |
| Part B MAD - Cohort 1 | Experimental | Drug: RXC007, Drug: RXC007 Matching PlaceboThis is the first treatment arm in Part B (Multiple Ascending Dose) of the study. 4 participants will be randomised to receive a selected dose of RXC007 (following Dose Escalation Data Review of SAD cohort data) once daily for 14 days. The remaining 2 participants will receive matching placebo. |
| Part B MAD - Cohort 2 | Experimental | Drug: RXC007, Drug: RXC007 Matching PlaceboThis is the second treatment arm in Part B (Multiple Ascending Dose) of the study. 4 participants will be randomised to receive a selected dose of RXC007 (following Dose Escalation Data Review of SAD and previous MAD cohort data) once daily for 14 days. The remaining 2 participants will receive matching placebo. |
| Part B MAD - Optional Cohort 3 | Experimental | Drug: RXC007, Drug: RXC007 Matching PlaceboThis is an optional third treatment arm in Part B (Multiple Ascending Dose) of the study. If deemed as necessary following Dose Escalation Data Review of previous cohorts data, up to 8 participants may be enrolled into this optional cohort. If enrolled, up to 6 participants will be randomised to receive a selected dose of RXC007 (following Dose Escalation Data Review of previous cohorts data) once daily for 14 days. The remaining 2 participants will receive matching placebo. |
| Part B MAD - Optional Cohort 4 | Experimental | Drug: RXC007, Drug: RXC007 Matching PlaceboThis is an optional fourth treatment arm in Part B (Multiple Ascending Dose) of the study. If deemed as necessary following Dose Escalation Data Review of previous cohorts data, up to 8 participants may be enrolled into this optional cohort. If enrolled, up to 6 participants will be randomised to receive a selected dose of RXC007 (following Dose Escalation Data Review of previous cohorts data) once daily for 14 days. The remaining 2 participants will receive matching placebo. |
| Part A SAD - Optional Cohort 9 | Experimental | Drug: RXC007, Drug: RXC007 Matching PlaceboThis is an optional ninth treatment arm in Part A (Single Ascending Dose) of the study. If deemed as necessary following Dose Escalation Data Review of previous cohorts data, up to 8 participants may be enrolled into this optional cohort. If enrolled, up to 6 participants will be randomised to receive a selected dose of RXC007 (following Dose Escalation Data Review of previous cohorts data) on one occasion on Day 1. The remaining 2 participants will receive matching placebo. |
| Part A SAD - Optional Cohort 10 | Experimental | Drug: RXC007, Drug: RXC007 Matching PlaceboThis is an optional tenth treatment arm in Part A (Single Ascending Dose) of the study. If deemed as necessary following Dose Escalation Data Review of previous cohorts data, up to 8 participants may be enrolled into this optional cohort. If enrolled, up to 6 participants will be randomised to receive a selected dose of RXC007 (following Dose Escalation Data Review of previous cohorts data) on one occasion on Day 1. The remaining 2 participants will receive matching placebo. |
| Part B MAD - Optional Cohort 5 | Experimental | Drug: RXC007, Drug: RXC007 Matching PlaceboThis is an optional fifth treatment arm in Part B (Multiple Ascending Dose) of the study. If deemed as necessary following Dose Escalation Data Review of previous cohorts data, up to 8 participants may be enrolled into this optional cohort. If enrolled, up to 6 participants will be randomised to receive a selected dose of RXC007 (following Dose Escalation Data Review of previous cohorts data) once daily for 14 days. The remaining 2 participants will receive matching placebo. |
| Part B MAD - Optional Cohort 6 | Experimental | Drug: RXC007, Drug: RXC007 Matching PlaceboThis is an optional sixth treatment arm in Part B (Multiple Ascending Dose) of the study. If deemed as necessary following Dose Escalation Data Review of previous cohorts data, up to 8 participants may be enrolled into this optional cohort. If enrolled, up to 6 participants will be randomised to receive a selected dose of RXC007 (following Dose Escalation Data Review of previous cohorts data) once daily for 14 days. The remaining 2 participants will receive matching placebo. |
| Part C DDI - Cohort 1 Rosuvastatin | Experimental | Drug: RXC007This is the first treatment arm in Part C (Drug-Drug Interaction) of the study. All participants within the cohort (12 participants) will to receive a selected dose of RXC007 (following Dose Escalation Data Review from Part A and Part B) and 10 mg rosuvastatin as follows: single dose of rosuvastatin (10 milligrams) on Day 1 followed by three single doses of RXC007 on Day 6, Day 7 \& Day 8 before taking a single dose of both RXC007 and rosuvastatin together on Day 9. |
| Part C DDI - Cohort 2 Metformin | Experimental | Drug: RXC007This is the second treatment arm in Part C (Drug-Drug Interaction) of the study. All participants within the cohort (12 participants) will to receive a selected dose of RXC007 (following Dose Escalation Data Review from Part A and Part B) and 500 mg metformin as follows: single dose of metformin (500 milligrams) on Day 1 followed by three single doses of RXC007 on Day 4, Day 5 \& Day 6 before taking a single dose of both RXC007 and metformin together on Day 7. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Healthy male participants, between 18 and 55 years of age, inclusive.
- Male participant (and female partner of childbearing potential) willing to use a highly effective method of contraception or 2 effective methods of contraception, if applicable (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the participant) from first dose until 3 months after last dose of IMP/NIMP.
- Participant with a body mass index (BMI) of 18.0-32.0 kg/m2.
- Participant with a body weight of 60 kg or greater.
- No clinically significant history of previous allergy / sensitivity to RXC007, rosuvastatin or metformin, or any of the excipients contained within the IMP/NIMP.
Key exclusion criteria (13 listed)
- A clinically significant history of gastrointestinal disorder likely to influence IMP/NIMP absorption.
- A clinically significant history of infection in the last 3 months.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements, antacids (Part C Cohort 1 only), any product known to be a substrate mainly metabolised by CYP enzymes within 28 days or 5 half-lives (whichever is longer) prior to the first dose of IMP/NIMP.
- Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- Participants who are unable to demonstrate the ability to swallow multiple "dummy" capsules (i.e., an empty gelatin capsules) of the size proposed for administration in a particular cohort/dose level (up to and including size 00).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RXC007RXC007 will be administered in the form of oral capsules at selected doses starting at 2 mg to 4 of the 6 participants within each cohort in Part A and Part B. For Part A, dosing frequency is one single dose on one occasion and for Part B, dosing frequency is single doses once daily for 14 days. If required, following dose escalation data review, dosing frequency and duration may be modified in Part B. All participants in Part C (24) will receive active RXC007 in the form of oral capsules as single doses. | Drug | Part A SAD - Cohort 1, Part A SAD - Cohort 2, Part A SAD - Cohort 3, Part A SAD - Cohort 4, Part A SAD - Cohort 5, Part A SAD - Cohort 6, Part A SAD - Optional Cohort 10, Part A SAD - Optional Cohort 7, Part A SAD - Optional Cohort 8, Part A SAD - Optional Cohort 9, Part B MAD - Cohort 1, Part B MAD - Cohort 2, Part B MAD - Optional Cohort 3, Part B MAD - Optional Cohort 4, Part B MAD - Optional Cohort 5, Part B MAD - Optional Cohort 6, Part C DDI - Cohort 1 Rosuvastatin, Part C DDI - Cohort 2 Metformin |
| RXC007 Matching PlaceboThe matching placebo for RXC007 will be administered in the form of oral capsules matched to the number of active RXC007 capsules at each dose level to 2 of the 6 participants within each cohort in Part A and Part B. For Part A, dosing frequency is one placebo dose on one occasion and for Part B, dosing frequency is single placebo doses once daily for 14 days. If required, following dose escalation data review, dosing frequency and duration may be modified in Part B. There is no placebo intervention for Part C of the study. | Drug | Part A SAD - Cohort 1, Part A SAD - Cohort 2, Part A SAD - Cohort 3, Part A SAD - Cohort 4, Part A SAD - Cohort 5, Part A SAD - Cohort 6, Part A SAD - Optional Cohort 10, Part A SAD - Optional Cohort 7, Part A SAD - Optional Cohort 8, Part A SAD - Optional Cohort 9, Part B MAD - Cohort 1, Part B MAD - Cohort 2, Part B MAD - Optional Cohort 3, Part B MAD - Optional Cohort 4, Part B MAD - Optional Cohort 5, Part B MAD - Optional Cohort 6 |
Primary outcome
Treatment Emergent Adverse Events
Time frame: Collection of TEAEs occurs through ad hoc reporting from the participants from the point of first dose administration (Day 1 in each part) through to study completion (up to 6 weeks for Part A & up to 8 weeks for Part B & C).
This primary endpoint relates to the number of participants who report a treatment emergent adverse event (TEAEs) across all study parts.
Number of participants who report a change from normal range values for laboratory safety parameters (serum biochemistry, serum haematology or urinalysis) from first dose on Day 1 to post-study follow up visit.
Time frame: Part A: From Day 1 to post-study follow up visit (up to 6 weeks) & Part B/C: From Day 1 to post-study follow up visit (up to 8 weeks)
This primary endpoint will report the number of participants within each cohort of Part A, Part B \& Part C of the study who record a value which is deemed as outside of the normal range (regardless of clinical significance) for any of the serum biochemistry, serum haematology or urinalysis parameters as defined in the study protocol following first dose administration on Day 1 up to completion of the post-study visit.
Number of participants who report a change from normal range values for vital signs parameters (blood pressure, pulse rate, respiration rate, oral body temperature) from first dose on Day 1 to post-study follow up visit.
Time frame: Part A: From Day 1 to post-study follow up visit (up to 6 weeks) & Part B/C: From Day 1 to post-study follow up visit (up to 8 weeks)
This primary endpoint will report the number of participants within each cohort of Part A, Part B \& Part C of the study who record a value which is deemed as outside of the normal range (regardless of clinical significance) for any of the vital signs parameters (systolic/diastolic blood pressure, pulse rate, respiration rate, oral body temperature) as defined in the study protocol following first dose administration on Day 1 up to completion of the post-study visit.
Number of participants who report a change from normal range values for any of the associated 12-Lead ECG parameters (heart rate, PR interval, QRS width, QT interval and QTcF interval) from first dose on Day 1 to post-study follow up visit.
Time frame: Part A: From Day 1 to post-study follow up visit (up to 6 weeks) & Part B/C: From Day 1 to post-study follow up visit (up to 8 weeks)
This primary endpoint will report the number of participants within each cohort of Part A, Part B \& Part C of the study who record a value which is deemed as outside of the normal range (regardless of clinical significance) for any of the 12-Lead ECG parameters (heart rate, PR interval, QRS width, QT interval and QTcF interval) as defined in the study protocol following first dose administration on Day 1 up to completion of the post-study visit.
30 secondary outcomes
Pharmacokinetic Parameters - Part A - Maximum observed concentration (Cmax)
Time frame: Plasma samples for Cmax evaluation of RXC007 in Part A: Day 1 pre-dose, 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr, 48 hr, 72 hr post-dose & post-study follow up (up to 6 weeks for Part A).
Pharmacokinetic Parameters - Part A - Time to maximum observed concentration (Tmax)
Time frame: Plasma samples for Tmax evaluation of RXC007 in Part A: Day 1 pre-dose, 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr, 48 hr, 72 hr post-dose & post-study follow up (up to 6 weeks for Part A).
Pharmacokinetic Parameters - Part A - Elimination rate constant (λz)
Time frame: Plasma samples for λz evaluation of RXC007 in Part A: Day 1 pre-dose, 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr, 48 hr, 72 hr post-dose & post-study follow up (up to 6 weeks for Part A).
Pharmacokinetic Parameters - Part A - Terminal elimination half-life (t1/2)
Time frame: Plasma samples for t1/2 evaluation of RXC007 in Part A: Day 1 pre-dose, 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr, 48 hr, 72 hr post-dose & post-study follow up (up to 6 weeks for Part A).
Pharmacokinetic Parameters - Part A - Area under the concentration-time curve (AUC) from the time of dosing to the time of the last measurable concentration (AUC0-t)
Time frame: Plasma samples for AUC0-t evaluation of RXC007 in Part A: Day 1 pre-dose, 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr, 48 hr, 72 hr post-dose & post-study follow up (up to 6 weeks for Part A).
Pharmacokinetic Parameters - Part A - Area under the concentration-time curve (AUC) extrapolated to infinity (AUC0-inf)
Time frame: Plasma samples for AUC0-inf evaluation of RXC007 in Part A: Day 1 pre-dose, 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr, 48 hr, 72 hr post-dose & post-study follow up (up to 6 weeks for Part A).
Pharmacokinetic Parameters - Part A - Residual Area (AUC%extrapolated)
Time frame: Plasma samples for AUC%extrapolated evaluation of RXC007 in Part A: Day 1 pre-dose, 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr, 48 hr, 72 hr post-dose & post-study follow up (up to 6 weeks for Part A).
Pharmacokinetic Parameters - Part A - Total apparent clearance following extravascular administration (CL/F)
Time frame: Plasma samples for CL/F evaluation of RXC007 in Part A: Day 1 pre-dose, 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr, 48 hr, 72 hr post-dose & post-study follow up (up to 6 weeks for Part A).
Pharmacokinetic Parameters - Part A - Apparent volume of distribution following extravascular administration (Vz/F)
Time frame: Plasma samples for Vz/F evaluation of RXC007 in Part A: Day 1 pre-dose, 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr, 48 hr, 72 hr post-dose & post-study follow up (up to 6 weeks for Part A).
Pharmacokinetic Parameters - Part B - Maximum observed concentration (Cmax)
Time frame: Plasma samples for Cmax evaluation of RXC007 in Part B: Day 1 & 14: 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr post-dose, Day 7, Day 16: 48 hr post-Day 14 dose & Day 17: 72 hr post-Day 14 dose (up to 8 weeks for Part B).
Pharmacokinetic Parameters - Part B - Time to maximum observed concentration (Tmax)
Time frame: Plasma samples for Tmax evaluation of RXC007 in Part B: Day 1 & 14: 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr post-dose, Day 7, Day 16: 48 hr post-Day 14 dose & Day 17: 72 hr post-Day 14 dose (up to 8 weeks for Part B).
Pharmacokinetic Parameters - Part B - Elimination rate constant (λz)
Time frame: Plasma samples for λz evaluation of RXC007 in Part B: Day 1 & 14: 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr post-dose, Day 7, Day 16: 48 hr post-Day 14 dose & Day 17: 72 hr post-Day 14 dose (up to 8 weeks for Part B).
Pharmacokinetic Parameters - Part B - Terminal elimination half-life (t1/2)
Time frame: Plasma samples for t1/2 evaluation of RXC007 in Part B: Day 1 & 14: 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr post-dose, Day 7, Day 16: 48 hr post-Day 14 dose & Day 17: 72 hr post-Day 14 dose (up to 8 weeks for Part B).
Pharmacokinetic Parameters - Part B - Area under the concentration-time curve (AUC) from 0 to τ, where τ is the dosing interval (0 - 24 h) (AUC0-τ)
Time frame: Plasma samples for AUC0-τ evaluation of RXC007 in Part B: Day 1 & 14: 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr post-dose, Day 7, Day 16: 48 hr post-Day 14 dose & Day 17: 72 hr post-Day 14 dose (up to 8 weeks for Part B).
Pharmacokinetic Parameters - Part B - Area under the concentration-time curve (AUC) from the time of dosing to the time of the last measurable concentration (AUC0-t)
Time frame: Plasma samples for AUC0-t evaluation of RXC007 in Part B: Day 1 & 14: 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr post-dose, Day 7, Day 16: 48 hr post-Day 14 dose & Day 17: 72 hr post-Day 14 dose (up to 8 weeks for Part B).
Pharmacokinetic Parameters - Part B - Area under the concentration-time curve (AUC) extrapolated to infinity (AUC0-inf)
Time frame: Plasma samples for AUC0-inf evaluation of RXC007 in Part B: Day 1 & 14: 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr post-dose, Day 7, Day 16: 48 hr post-Day 14 dose & Day 17: 72 hr post-Day 14 dose (up to 8 weeks for Part B).
Pharmacokinetic Parameters - Part B - Residual area (AUC%extrapolated)
Time frame: Plasma samples for AUC%extrapolated evaluation of RXC007 in Part B: Day 1 & 14: 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr post-dose, Day 7, Day 16: 48 hr post-Day 14 dose & Day 17: 72 hr post-Day 14 dose (up to 8 weeks for Part B).
Pharmacokinetic Parameters - Part B - Accumulation ratio calculated from Cmax (ARCmax)
Time frame: Plasma samples for ARCmax evaluation of RXC007 in Part B: Day 1 & 14: 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr post-dose, Day 7, Day 16: 48 hr post-Day 14 dose & Day 17: 72 hr post-Day 14 dose (up to 8 weeks for Part B).
Pharmacokinetic Parameters - Part B - Accumulation ratio calculated from AUC (ARAUC)
Time frame: Plasma samples for ARAUC evaluation of RXC007 in Part B: Day 1 & 14: 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr post-dose, Day 7, Day 16: 48 hr post-Day 14 dose & Day 17: 72 hr post-Day 14 dose (up to 8 weeks for Part B).
Pharmacokinetic Parameters - Part B - Total apparent clearance following extravascular administration (CL/F)
Time frame: Plasma samples for CL/F evaluation of RXC007 in Part B: Day 1 & 14: 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr post-dose, Day 7, Day 16: 48 hr post-Day 14 dose & Day 17: 72 hr post-Day 14 dose (up to 8 weeks for Part B).
Pharmacokinetic Parameters - Part B - Apparent volume of distribution following extravascular administration (Vz/F)
Time frame: Plasma samples for Vz/F evaluation of RXC007 in Part B: Day 1 & 14: 15 mins, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr post-dose, Day 7, Day 16: 48 hr post-Day 14 dose & Day 17: 72 hr post-Day 14 dose (up to 8 weeks for Part B).
Pharmacokinetic Parameters - Part C - Maximum observed concentration (Cmax)
Time frame: Plasma samples for Cmax evaluation of in Part C: Maximum of 34 samples in Cohort 1 from Day 1 pre-dose to Day 13 and maximum of 33 samples in Cohort 2 from Day 1 pre-dose to Day 10
Pharmacokinetic Parameters - Part C - Time to maximum observed concentration (Tmax)
Time frame: Plasma samples for Tmax evaluation of in Part C: Maximum of 34 samples in Cohort 1 from Day 1 pre-dose to Day 13 and maximum of 33 samples in Cohort 2 from Day 1 pre-dose to Day 10
Pharmacokinetic Parameters - Part C - Elimination rate constant (λz)
Time frame: Plasma samples for λz evaluation of in Part C: Maximum of 34 samples in Cohort 1 from Day 1 pre-dose to Day 13 and maximum of 33 samples in Cohort 2 from Day 1 pre-dose to Day 10
Pharmacokinetic Parameters - Part C - Terminal elimination half-life (t1/2)
Time frame: Plasma samples for t1/2 evaluation of in Part C: Maximum of 34 samples in Cohort 1 from Day 1 pre-dose to Day 13 and maximum of 33 samples in Cohort 2 from Day 1 pre-dose to Day 10
Pharmacokinetic Parameters - Part C - Area under the concentration-time curve (AUC) from the time of dosing to the time of the last measurable concentration (AUC0-t)
Time frame: Plasma samples for AUC0-t evaluation of in Part C: Maximum of 34 samples in Cohort 1 from Day 1 pre-dose to Day 13 and maximum of 33 samples in Cohort 2 from Day 1 pre-dose to Day 10
Pharmacokinetic Parameters - Part C - Area under the concentration-time curve (AUC) extrapolated to infinity (AUC0-inf)
Time frame: Plasma samples for AUC0-inf evaluation of in Part C: Maximum of 34 samples in Cohort 1 from Day 1 pre-dose to Day 13 and maximum of 33 samples in Cohort 2 from Day 1 pre-dose to Day 10
Pharmacokinetic Parameters - Part C - Residual area (AUC%extrapolated)
Time frame: Plasma samples for AUC%extrapolated evaluation of in Part C: Maximum of 34 samples in Cohort 1 from Day 1 pre-dose to Day 13 and maximum of 33 samples in Cohort 2 from Day 1 pre-dose to Day 10
Pharmacokinetic Parameters - Part C - Total apparent clearance following extravascular administration (CL/F)
Time frame: Plasma samples for CL/F evaluation of in Part C: Maximum of 34 samples in Cohort 1 from Day 1 pre-dose to Day 13 and maximum of 33 samples in Cohort 2 from Day 1 pre-dose to Day 10
Pharmacokinetic Parameters - Part C - Apparent volume of distribution following extravascular administration (Vz/F)
Time frame: Plasma samples for Vz/F evaluation of in Part C: Maximum of 34 samples in Cohort 1 from Day 1 pre-dose to Day 13 and maximum of 33 samples in Cohort 2 from Day 1 pre-dose to Day 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No. At this stage, it is not planned that any IPD information will be shared with other researchers outside of the Sponsor and Clinical Research Organisation undertaking the conduct of this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annelize Koch principal investigator
Simbec-Orion Clinical Pharmacology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RXC007 in people with Fibrosis and Inflammation, run by Redx Pharma Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Emergent Adverse Events (time frame: Collection of TEAEs occurs through ad hoc reporting from the participants from the point of first dose administration (Day 1 in each part) through to study completion (up to 6 weeks for Part A & up to 8 weeks for Part B & C).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.