PharmacokineticPhase 1NCT04617509
A Study in Healthy Subjects to Evaluate Pharmacokinetics and Food Effect After Dosing of GS-248
A Phase 1 study testing Formulation A GS-248 and Formulation B GS-248 in people with Pharmacokinetic, run by Gesynta Pharma AB at 1 site in Sweden.
Trial summary
The study will collect information about pharmacokinetics (PK), safety and tolerability following a single dose of GS-248 in two different oral solid formulations in capsules to healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetic
- What is being tested?
- Formulation A GS-248 and Formulation B GS-248
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSweden
- Study dates
- 31 Mar 2020to 27 May 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing and able to give written informed consent for participation in the study.
- Healthy male or female subject aged ≥ 18 and ≤70 years.
- Body Mass Index (BMI) ≥ 19.0 and ≤ 30.0 kg/m2.
- Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.
- Women of child bearing potential (WOCBP) must practice abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the subject) or must agree to use a highly effective method of contraception with a failure rate of < 1% to prevent pregnancy (combined [oestrogen and progestogen containing] hormonal contraception [oral, intravaginal, transdermal], progestogen-only hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable], intrauterine device [IUD]or intrauterine hormone-releasing system [IUS]) from at least 4 weeks prior to dose to 4 weeks after last dose.
Who cannot join
- Known allergy to GS-248.
- Females who are breast feeding or who plan to become pregnant until 2 weeks after the end-of-study visit.
- Positive serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) at screening and within 24 h prior to the first administration of IMP.
- Regular use of corticosteroids (inhaled and systemic), NSAIDs, aspirin or coxibs, antacids, PPIs, or any other medication that changes gastric pH within 14 days of study drug administration.
- Regular use of any prescribed or non-prescribed medication including analgesics, herbal remedies, vitamins and minerals within 2 weeks prior to the (first) administration of IMP, except hormonal contraception and occasional intake of paracetamol (maximum 2000 mg/day; and not exceeding 3000 mg/week) and nasal decongestants without cortisone, antihistamine or anticholinergics for a maximum of 10 days, at the discretion of the Investigator.
- Presence of inherited or acquired disorders of platelet function, bleeding or coagulation, as judged by the investigator.
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- History or presence of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- After 10 minutes supine rest at the time of screening, any vital signs values outside the following ranges:
- Systolic blood pressure <90 or >140 mmHg, or
- Diastolic blood pressure <50 or >90 mmHg, or
- Pulse <40 or >90 bpm
- Positive test for serum hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or HIV 1 and/or 2 antibodies at screening.
- Presence or history of drug and/or alcohol abuse and/or excessive intake of alcohol and/or history, or current use, of anabolic steroids, as judged by the Investigator.
- Positive test for drugs of abuse or alcohol at screening or on admission to the unit prior to administration of the IMP.
- Participation in other interventional studies within 3 months prior to administration of study drug.
- Consumption of grapefruit, grapefruit juice, other grapefruit-containing products, or Seville oranges within 14 days of first IMP administration.
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
- Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma.
- Any planned major surgery within the duration of the study.
- Prolonged QTcF (>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG, as judged by the Investigator.
- Current smokers or users of nicotine products. Irregular use of nicotine (e.g., smoking, snuffing, chewing tobacco) less than three times per week is allowed before screening visit.
- Regular excessive caffeine consumption defined by a daily intake of >5 cups of caffeine-containing beverages.
- Intake of xanthine- and/or taurine-containing energy drinks within 2 days prior to screening and prior to IMP administration.
- Plasma donation within one month of screening or blood donation (or corresponding blood loss) during three months prior to screening.
- Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.
- Estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73 m2 (determined by the revised Lund-Malmö GFR estimating equation).
- Subjects with swallowing disorders, which may affect the subject´s capability to swallow the IMP.
- Subjects who are vegetarian or for other reasons cannot eat the high-fat high-calorie breakfast.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, One-sequence, Three-period Study in Healthy Subjects to Evaluate Pharmacokinetics and Food Effect After Oral Single Dosing of Two Different Solid Formulations of GS-248
The study will collect information about pharmacokinetics (PK), safety and tolerability following a single dose of GS-248 in two different oral solid formulations in capsules to healthy subjects. It will also collect information about pharmacokinetics (PK), safety and tolerability following a single dose of one of the two formulations of GS-248 in fed condition.
Read the detailed description
The study is divided in two parts. Part I will evaluate PK, safety and tolerability of a single oral dose of two different formulations of GS-248 in fasting conditions. Part II will evaluate PK, safety and tolerability of one of the two different formulations of GS-248 in fed conditions.
In Part I, a single oral dose of GS-248 in two different solid formulations will be administered to 14 healthy subjects. All subjects will first receive Formulation A and then Formulation B. A wash-out period of at least 4 days will be applied between the IMP administrations. Both doses contain 120 mg GS 248. For Part I, subjects will come to the clinic for single dose administration of Formulation A or Formulation B, respectively, and PK and safety assessments. Safety assessments include AE reporting, physical examination, ECG, vital signs, body temperature, and blood sampling for analysis of safety laboratory parameters.
After evaluation of the PK profiles of Formulation A and B in Part I of the study, one formulation will be selected to be given following intake of a standardised breakfast in Part II of the study. Subjects will return to the clinic for a second dose of the selected formulation, yet now in fed conditions. The assessments during fed conditions will be the same as during fasting conditions except that the subjects will consume a high-fat high-calorie breakfast 30 minutes prior to IMP administration.
- Conditions
- Pharmacokinetic
- Being tested
- Formulation A GS-248, Formulation B GS-248
- Keywords
- Pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formulation A GS-248Drug
Formulation A of GS-248 in a capsule, dose 120 mg given as a single-dose of 3 capsules a´40 mg.
Formulation B GS-248Drug
Formulation B of GS-248 in a capsule, dose 120 mg given as a single-dose of 3 capsules a´40 mg.
| Study group | Role | What they receive |
|---|---|---|
| Part I GS-248 Formulation A | Experimental | Formulation A given in fasting state. Receives: Drug: Formulation A GS-248 |
| Part I GS-248 Formulation B | Active comparator | Formulation B given in fasting state. Receives: Drug: Formulation B GS-248 |
| Part II GS-248 Formulation A or B | Other | Formulation A or B given in fed condition Receives: Drug: Formulation A GS-248; Drug: Formulation B GS-248 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
The Maximal Plasma Concentration (Cmax) after a single dose of Formulation A and B of GS 248 respectively in fasting conditions and after a single dose of Formulation A of GS-248 in fed condition.
Blood samples for bioanalysis of GS-248 and subsequent PK analysis were collected as venous blood samples.
Measured: From time 0 (time of dosing) to 48 hours after dose (concentration measured at timepoints pre-dose and 0:15, 0:30, 1, 1:30, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
AUC0-inf
The Area Under the Curve (AUC) for the time interval 0-infinity of GS-248 after a single dose of Formulation A and B of GS 248 respectively in fasting conditions and after a single dose of Formulation A of GS-248 in fed condition. The mean AUC of GS-248 was assessed by means of non-compartmental analysis (NCA).
Blood samples for bioanalysis of GS-248 and subsequent PK analysis were collected as venous blood samples.
Measured: From time 0 (time of dosing) to 48 hours after dose (concentration measured at timepoints pre-dose and 0:15, 0:30, 1, 1:30, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
AUC0-24h
The Area Under the Curve (AUC) for the time interval 0-24h of GS-248 after a single dose of Formulation A and B of GS 248 respectively in fasting conditions and after a single dose of Formulation A of GS-248 in fed condition. The mean AUC of GS-248 for the time interval 0-24 h was assessed by means of non-compartmental analysis (NCA).
Blood samples for bioanalysis of GS-248 and subsequent PK analysis were collected as venous blood samples.
Measured: From time 0 (time of dosing) to 24 hours after dose (concentration measured at timepoints pre-dose and 0:15, 0:30, 1, 1:30, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
Tmax
Time to Cmax (Tmax) after a single dose of Formulation A and B of GS 248 respectively in fasting conditions and after a single dose of Formulation A of GS-248 in fed condition.
Blood samples for bioanalysis of GS-248 and subsequent PK analysis were collected as venous blood samples.
Measured: From time 0 (time of dosing) to 48 hours after dose (concentration measured at timepoints pre-dose and 0:15, 0:30, 1, 1:30, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
T1/2(z)
Plasma half-life associated with the terminal elimination phase (T1/2(z)) after a single dose of Formulation A and B of GS 248 respectively in fasting conditions and after a single dose of Formulation A of GS-248 in fed condition.
Blood samples for bioanalysis of GS-248 and subsequent PK analysis were collected as venous blood samples.
Measured: T1/2 (z) was assessed for the terminal elimination phase up to 48 hours
Vz/F
The mean volume of distribution (Vz/F) after a single dose of Formulation A and B of GS 248 respectively in fasting conditions and after a single dose of Formulation A of GS-248 in fed condition.
Blood samples for bioanalysis of GS-248 and subsequent PK analysis were collected as venous blood samples.
Measured: Vz/F was assessed for the terminal elimination phase up to 48 hours.
CL/F
The mean total clearance (CL/F) after a single dose of Formulation A and B of GS 248 respectively in fasting conditions and after a single dose of Formulation A of GS-248 in fed condition.
The mean total clearance (CL/F) was calculated by non-compartmental analysis (NCA).
Blood samples for bioanalysis of GS-248 and subsequent PK analysis were collected as venous blood samples.
Measured: CL/F was assessed for a single dose of GS-248 up to 48 hours.
Secondary outcomes (5)
Number of Treatment Related Adverse Events
The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed by the Investigator as "unlikely", "possibly" or "probably" related to the IMP. An AE was considered causally related to the use of the IMP when the causality assessment was "probable" or "possible".
Measured: AEs (including serious AEs [SAEs]) were collected from the start of IMP application in Part I until the end-of- study visit i.e. Visit 7, day 3, up to 30 days.
Number of Clinically Significant (CS) Changes in Physical Examination
A complete physical examination included assessments of the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes and extremities. A short version of physical examination included an assessment of selected body systems at the judgement of the Investigator but at least included cardiovascular, lung and abdomen.
The results of the examinations were documented in the eCRF as normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). Post-dose physical examination findings judged as abnormal CS were reported as AEs.
Measured: Physical examination was performed at pre-defined timepoints from the Screening Visit until the End-of- Study Visit i.e. Visit 7, day 3, up to 30 days.
Number of Clinically Significant (CS) Changes in Vital Signs
Systolic and diastolic blood pressure and pulse were measured in supine position after 10 minutes of rest. Vital signs were judged as normal, abnormal NCS or abnormal CS.
Measured: Vital signs ware assessed at pre-defined timepoints from the Screening Visit until the End-of- Study Visit i.e. Visit 7, day 3, up to 30 days.
Number of Clinically Significant (CS) Changes in Resting 12-lead Electrocardiogram (ECG)
Single 12-lead ECG was recorded in supine position after 10 minutes of rest using an ECG machine. HR and PR, QRS, QT and QTcF intervals were recorded. Safety ECGs were reviewed and interpreted on-site by the Investigator. All ECGs were categorised as "normal", "abnormal, not clinically significant", or "abnormal, clinically significant".
Measured: ECG evaluation was assessed at pre-defined timepoints from the Screening Visit until the End-of- Study Visit i.e. Visit 7, day 3, up to 30 days.
Number of Clinically Significant (CS) Changes in Safety Laboratory Parameters
Blood samples for analysis of clinical chemistry and haematology parameters were collected through venepuncture or an indwelling venous catheter and sent to the certified clinical chemistry laboratory at Uppsala University Hospital and analysed by routine analytical methods. Urine analysis was performed at the research clinic using dip sticks. Safety laboratory parameters were judged as normal, abnormal NCS or abnormal CS.
Measured: Blood samples were collected at pre-defined timepoints from the Screening Visit until the End-of- Study Visit i.e. Visit 7, day 3, up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start31 Mar 2020
- Primary completion27 May 2020
- Study completion27 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PharmacokineticStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- The study is divided in two parts. Part I will evaluate PK, safety and tolerability of a single oral dose of two different formulations of GS-248 in fasting conditions. Part II will evaluate PK, safety and tolerability of one of the two different formulations of GS-248 in fed conditions. Subjects are expected to participate in both Part I and Part II.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gesynta Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB, Research Institutes of Sweden
- Responsible party
- Sponsor
- Investigators
- Helena Litorp, MD, PhD, Principal investigator, CTC Clinical Trial Consultants AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617509
- Sponsor's protocol ID
- GS-1002
- Status last verified
- Aug 2021
- First submitted
- 27 May 2020
- Last updated
- 31 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, One-sequence, Three-period Study in Healthy Subjects to Evaluate Pharmacokinetics and Food Effect After Oral Single Dosing of Two Different Solid Formulations of GS-248
- ClinicalTrials.gov ID
- NCT04617509
- Acronym / sponsor ID
- GS-1002
- Conditions
- Pharmacokinetic
- Keywords
- Pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Gesynta Pharma ABIndustry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB, Research Institutes of Sweden
- Study start
- 31 Mar 2020 (actual)
- Primary completion
- 27 May 2020 (actual)
- Study completion
- 27 May 2020 (actual)
- First posted
- 5 Nov 2020 (actual)
- Results
- Posted 31 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will collect information about pharmacokinetics (PK), safety and tolerability following a single dose of GS-248 in two different oral solid formulations in capsules to healthy subjects. It will also collect information about pharmacokinetics (PK), safety and tolerability following a single dose of one of the two formulations of GS-248 in fed condition.
Detailed description
The study is divided in two parts. Part I will evaluate PK, safety and tolerability of a single oral dose of two different formulations of GS-248 in fasting conditions. Part II will evaluate PK, safety and tolerability of one of the two different formulations of GS-248 in fed conditions.
In Part I, a single oral dose of GS-248 in two different solid formulations will be administered to 14 healthy subjects. All subjects will first receive Formulation A and then Formulation B. A wash-out period of at least 4 days will be applied between the IMP administrations. Both doses contain 120 mg GS 248. For Part I, subjects will come to the clinic for single dose administration of Formulation A or Formulation B, respectively, and PK and safety assessments. Safety assessments include AE reporting, physical examination, ECG, vital signs, body temperature, and blood sampling for analysis of safety laboratory parameters.
After evaluation of the PK profiles of Formulation A and B in Part I of the study, one formulation will be selected to be given following intake of a standardised breakfast in Part II of the study. Subjects will return to the clinic for a second dose of the selected formulation, yet now in fed conditions. The assessments during fed conditions will be the same as during fasting conditions except that the subjects will consume a high-fat high-calorie breakfast 30 minutes prior to IMP administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study is divided in two parts. Part I will evaluate PK, safety and tolerability of a single oral dose of two different formulations of GS-248 in fasting conditions. Part II will evaluate PK, safety and tolerability of one of the two different formulations of GS-248 in fed conditions. Subjects are expected to participate in both Part I and Part II.
| Arm | Type | Receives |
|---|---|---|
| Part I GS-248 Formulation A | Experimental | Drug: Formulation A GS-248Formulation A given in fasting state. |
| Part I GS-248 Formulation B | Active comparator | Drug: Formulation B GS-248Formulation B given in fasting state. |
| Part II GS-248 Formulation A or B | Other | Drug: Formulation A GS-248, Drug: Formulation B GS-248Formulation A or B given in fed condition |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willing and able to give written informed consent for participation in the study.
- Healthy male or female subject aged ≥ 18 and ≤70 years.
- Body Mass Index (BMI) ≥ 19.0 and ≤ 30.0 kg/m2.
- Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.
- Women of child bearing potential (WOCBP) must practice abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the subject) or must agree to use a highly effective method of contraception with a failure rate of < 1% to prevent pregnancy (combined [oestrogen and progestogen containing] hormonal contraception [oral, intravaginal, transdermal], progestogen-only hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable], intrauterine device [IUD]or intrauterine hormone-releasing system [IUS]) from at least 4 weeks prior to dose to 4 weeks after last dose.
Key exclusion criteria (28 listed)
- Known allergy to GS-248.
- Females who are breast feeding or who plan to become pregnant until 2 weeks after the end-of-study visit.
- Positive serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) at screening and within 24 h prior to the first administration of IMP.
- Regular use of corticosteroids (inhaled and systemic), NSAIDs, aspirin or coxibs, antacids, PPIs, or any other medication that changes gastric pH within 14 days of study drug administration.
- Regular use of any prescribed or non-prescribed medication including analgesics, herbal remedies, vitamins and minerals within 2 weeks prior to the (first) administration of IMP, except hormonal contraception and occasional intake of paracetamol (maximum 2000 mg/day; and not exceeding 3000 mg/week) and nasal decongestants without cortisone, antihistamine or anticholinergics for a maximum of 10 days, at the discretion of the Investigator.
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 |
|---|---|---|
| Formulation A GS-248Formulation A of GS-248 in a capsule, dose 120 mg given as a single-dose of 3 capsules a´40 mg. | Drug | Part I GS-248 Formulation A, Part II GS-248 Formulation A or B |
| Formulation B GS-248Formulation B of GS-248 in a capsule, dose 120 mg given as a single-dose of 3 capsules a´40 mg. | Drug | Part I GS-248 Formulation B, Part II GS-248 Formulation A or B |
Primary outcome
Cmax
Time frame: From time 0 (time of dosing) to 48 hours after dose (concentration measured at timepoints pre-dose and 0:15, 0:30, 1, 1:30, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
The Maximal Plasma Concentration (Cmax) after a single dose of Formulation A and B of GS 248 respectively in fasting conditions and after a single dose of Formulation A of GS-248 in fed condition. Blood samples for bioanalysis of GS-248 and subsequent PK analysis were collected as venous blood samples.
AUC0-inf
Time frame: From time 0 (time of dosing) to 48 hours after dose (concentration measured at timepoints pre-dose and 0:15, 0:30, 1, 1:30, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
The Area Under the Curve (AUC) for the time interval 0-infinity of GS-248 after a single dose of Formulation A and B of GS 248 respectively in fasting conditions and after a single dose of Formulation A of GS-248 in fed condition. The mean AUC of GS-248 was assessed by means of non-compartmental analysis (NCA). Blood samples for bioanalysis of GS-248 and subsequent PK analysis were collected as venous blood samples.
AUC0-24h
Time frame: From time 0 (time of dosing) to 24 hours after dose (concentration measured at timepoints pre-dose and 0:15, 0:30, 1, 1:30, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
The Area Under the Curve (AUC) for the time interval 0-24h of GS-248 after a single dose of Formulation A and B of GS 248 respectively in fasting conditions and after a single dose of Formulation A of GS-248 in fed condition. The mean AUC of GS-248 for the time interval 0-24 h was assessed by means of non-compartmental analysis (NCA). Blood samples for bioanalysis of GS-248 and subsequent PK analysis were collected as venous blood samples.
Tmax
Time frame: From time 0 (time of dosing) to 48 hours after dose (concentration measured at timepoints pre-dose and 0:15, 0:30, 1, 1:30, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
Time to Cmax (Tmax) after a single dose of Formulation A and B of GS 248 respectively in fasting conditions and after a single dose of Formulation A of GS-248 in fed condition. Blood samples for bioanalysis of GS-248 and subsequent PK analysis were collected as venous blood samples.
T1/2(z)
Time frame: T1/2 (z) was assessed for the terminal elimination phase up to 48 hours
Plasma half-life associated with the terminal elimination phase (T1/2(z)) after a single dose of Formulation A and B of GS 248 respectively in fasting conditions and after a single dose of Formulation A of GS-248 in fed condition. Blood samples for bioanalysis of GS-248 and subsequent PK analysis were collected as venous blood samples.
Vz/F
Time frame: Vz/F was assessed for the terminal elimination phase up to 48 hours.
The mean volume of distribution (Vz/F) after a single dose of Formulation A and B of GS 248 respectively in fasting conditions and after a single dose of Formulation A of GS-248 in fed condition. Blood samples for bioanalysis of GS-248 and subsequent PK analysis were collected as venous blood samples.
CL/F
Time frame: CL/F was assessed for a single dose of GS-248 up to 48 hours.
The mean total clearance (CL/F) after a single dose of Formulation A and B of GS 248 respectively in fasting conditions and after a single dose of Formulation A of GS-248 in fed condition. The mean total clearance (CL/F) was calculated by non-compartmental analysis (NCA). Blood samples for bioanalysis of GS-248 and subsequent PK analysis were collected as venous blood samples.
5 secondary outcomes
Number of Treatment Related Adverse Events
Time frame: AEs (including serious AEs [SAEs]) were collected from the start of IMP application in Part I until the end-of- study visit i.e. Visit 7, day 3, up to 30 days.
Number of Clinically Significant (CS) Changes in Physical Examination
Time frame: Physical examination was performed at pre-defined timepoints from the Screening Visit until the End-of- Study Visit i.e. Visit 7, day 3, up to 30 days.
Number of Clinically Significant (CS) Changes in Vital Signs
Time frame: Vital signs ware assessed at pre-defined timepoints from the Screening Visit until the End-of- Study Visit i.e. Visit 7, day 3, up to 30 days.
Number of Clinically Significant (CS) Changes in Resting 12-lead Electrocardiogram (ECG)
Time frame: ECG evaluation was assessed at pre-defined timepoints from the Screening Visit until the End-of- Study Visit i.e. Visit 7, day 3, up to 30 days.
Number of Clinically Significant (CS) Changes in Safety Laboratory Parameters
Time frame: Blood samples were collected at pre-defined timepoints from the Screening Visit until the End-of- Study Visit i.e. Visit 7, day 3, up to 30 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Healthy Participants
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.
Helena Litorp, MD, PhD principal investigator
CTC Clinical Trial Consultants AB
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 Formulation A GS-248 and Formulation B GS-248 in people with Pharmacokinetic, run by Gesynta Pharma AB at 1 site in Sweden.
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 5 inclusion and 28 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 31 Aug 2021. 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 Sweden. 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?
Yes. Results are posted in the registry (first posted 31 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cmax (time frame: From time 0 (time of dosing) to 48 hours after dose (concentration measured at timepoints pre-dose and 0:15, 0:30, 1, 1:30, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose)). The study lists 7 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 31 Aug 2021.