HealthyPhase 1NCT03442621
Relacorilant Food Effect Study in Healthy Subjects
A Phase 1 study testing Relacorilant Fasted, Relacorilant with a high fat breakfast and Relacorilant with a moderate breakfast in people with Healthy and Food-drug Interaction, run by Corcept Therapeutics at 1 site in United States.
Trial summary
This is an open-label, randomized, single-dose, 3-period crossover, Williams' design, food-interaction (fasted and fed arms) study conducted in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Food-drug Interaction
- What is being tested?
- Relacorilant Fasted, Relacorilant with a high fat breakfast and Relacorilant with a moderate breakfast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2018to 9 Mar 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to understand the purpose and risks of the study; willing and able to adhere to scheduled visits, treatment plans, laboratory tests, and other study evaluations and procedures.
- Give written informed consent.
- Be males or nonpregnant, nonlactating females judged to be in good health, based on the results of medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory findings.
- Have a body mass index (BMI) between 18 and 32 kg/m2, inclusive, and a body weight more than 50 kg (110 pounds).
- Be a nonsmoker. Use of nicotine or nicotine-containing products must be discontinued at least 90 days prior to the first dose of study drug.
- Be willing to comply with study restrictions
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- Have suitable veins for multiple venipuncture/cannulation.
- Female subjects must be either of nonchildbearing potential (ie, postmenopausal or permanently sterilized) or use highly effective contraception with low user-dependency.
- The only acceptable method of highly effective contraception with low user-dependency is an intrauterine device (IUD). Use of hormonal contraception (by any route, including intrauterine hormone releasing systems) or hormone replacement therapy is NOT acceptable.
Who cannot join
- Be an employee or immediate family member of the Clinical Research Unit or Corcept.
- Have been previously enrolled in any study of relacorilant.
- Have multiple drug allergies, or be allergic to any of the components of relacorilant.
- Have a condition that could be aggravated by glucocorticoid blockade (eg, asthma, any chronic inflammatory condition).
- Have a history of gastric bypass surgery.
- Have a history of malabsorption syndrome or previous gastrointestinal surgery, with the exception of appendectomy and cholecystectomy, which could affect drug absorption or metabolism.
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- Current alcohol or substance abuse.
- In the 2 calendar months before first study drug administration, have donated/lost blood or plasma in excess of 400 mL.
- In the 30 days before first study drug administration, have participated in another clinical trial of a new chemical entity or a prescription medicine.
- Have a positive test for alcohol or drugs of abuse at screening or first admission.
- Have a positive test for exogenous glucocorticoids at screening.
- Have clinically relevant abnormal findings on vital signs, physical examination, laboratory screening tests, or 12-lead ECG, at screening and/or before first study drug administration, including but not limited to**:
- QT interval corrected for heart rate (QTc) using Fridericia's equation (QTcF) >450 ms (from mean of 3 supine ECGs, performed at least 2 minutes apart)
- Stage 2 or higher hypertension (supine/semi-recumbent systolic blood pressure [SBP] >160 mmHg, diastolic blood pressure [DBP] >100 mmHg; based on mean of duplicate values recorded at least 2 minutes apart)
- Stage 1 hypertension (supine/semi-recumbent SBP 140-160 mmHg, DBP 90-100 mmHg; based on mean of duplicate values recorded at least 2 minutes apart) associated with indication for treatment ie, evidence of end-organ damage, diabetes, or a 10-year cardiovascular risk, estimated using a standard calculator, (eg, QRISK2-2016) greater than 20%
- Glomerular filtration rate, estimated using the chronic kidney disease epidemiology (collaboration) (CKD-EPI) method (eGFR; Levey 2009) <60 mL/minute/1.73 m2
- Hypokalemia (potassium below lower limit of normal)
- Alanine aminotransferase (ALT), aspartate amino transferase (AST), and/or gamma- glutamyltransferase (GGT) >1.5 times the upper limit of normal (ULN)
- Seropositive for hepatitis B, hepatitis C, or human immunodeficiency (HIV) viruses **For purposes of qualifying any given subject for study participation, out-of-range values may be repeated once.
- Have any medical or social reasons for not participating in the study raised by their primary care physician.
- Have any other condition that might increase the risk to the individual or decrease the chance of obtaining satisfactory data, as assessed by the Investigator.
- Taken any prohibited prior medication within protocol designated timeframes, such as or including any glucocorticoid, strong inducers, inhibitors or substrates of CYP enzymes involved in drug-drug-interactions, hormonal contraception or hormone replacement therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Single-dose, Randomized, Crossover Study in Healthy Subjects of the Effects of Co-administration With Food on Exposure, and to Determine the Within-subject Variability in Exposure, to Relacorilant and Its Metabolites
This is an open-label, randomized, single-dose, 3-period crossover, Williams' design, food-interaction (fasted and fed arms) study conducted in healthy subjects.
Read the detailed description
This food-interaction study will be conducted in healthy subjects. Each subject will have a screening visit (within the 21 days prior to the first study drug administration to confirm eligibility), 3 single-dose treatment periods separated by a 7- to 14- day washout between doses, and an outpatient end-of-study follow-up visit 14 +/- 2 days after the last dose of study medication. During each treatment period, subjects will receive a single 350-mg relacorilant dose. Based on randomization to 1 of 6 sequences, each subject will receive the relacorilant dose once after a 10.5 hour fast; once 30 minutes after the start of a high-fat meal; and once 30 minutes after the start of a moderate meal.
During the first treatment period only, regardless of randomized sequence, subjects will report to the clinical research unit on the morning of Day -1 for baseline laboratory assessments and to collect samples for assay of messenger ribonucleic acid (mRNA) expression of glucocorticoid-modulated genes to explore the normal range over the day in healthy subjects. For the subsequent 2 treatment periods, subjects will report to the CRU on the evening of Day -1.
Blood samples for assay of plasma concentration of relacorilant and its main metabolites will be collected pre-dose and at 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, and 96 hours post-dose. Subjects and will remain in the clinic until after the 24-hour blood samples are collected and then be discharged and scheduled to return for the later samples.
Additional samples will be collected for possible future pharmacogenomic analysis.
- Conditions
- Healthy, Food-drug Interaction
- Being tested
- Relacorilant Fasted, Relacorilant with a high fat breakfast, Relacorilant with a moderate breakfast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relacorilant FastedDrug
Also called Relacorilant, CORT125134
Relacorilant, presented as 7 x 50-mg white, hard gelatin capsules for oral administration, given following a 10.5 h fast
Relacorilant with a high fat breakfastDrug
Also called Relacorilant, CORT125134
Relacorilant presented as 7 x 50-mg white, hard gelatin capsules for oral administration, given following a 10 h fast and 0.5 h after the start of a high fat breakfast
Relacorilant with a moderate breakfastDrug
Also called Relacorilant, CORT125134
Relacorilant, presented as 7 x 50-mg white, hard gelatin capsules for oral administration, given following a 10 h fast and 0.5 h after the start of a moderate breakfast
| Study group | Role | What they receive |
|---|---|---|
| Relacorilant Fasted | Experimental | Relacorilant Fasted Receives: Drug: Relacorilant Fasted |
| Relacorilant with a high fat breakfast | Experimental | Relacorilant with a high fat breakfast Receives: Drug: Relacorilant with a high fat breakfast |
| Relacorilant with a moderate breakfast | Experimental | Relacorilant with a moderate breakfast Receives: Drug: Relacorilant with a moderate breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under plasma concentration-time curve up to the last quantifiable sample (AUC0-tz)
Ratio of population geometric means (GMR) for Test 1 (standard high fat breakfast) and Reference (fasted) and for Test 2 (standard moderate breakfast) and Reference for relacorilant areas under plasma concentration-time curve up to the last quantifiable sample (AUC0-tz)
Measured: predose to 96 hrs postdose
Secondary outcomes (7)
Area under plasma concentration-time curve extrapolated to infinity (AUCinf)
Ratio of population geometric means (GMR) for Test 1 (standard high fat breakfast) and Reference (fasted) and for Test 2 (standard moderate breakfast) and Reference for relacorilant areas under plasma concentration-time curve extrapolated to infinity (AUCinf)
Measured: predose to 96 hrs postdose
Maximum plasma concentration (Cmax)
Ratio of population geometric means (GMR) for Test 1 (standard high fat breakfast) and Reference (fasted) and for Test 2 (standard moderate breakfast) and Reference for relacorilant maximum plasma concentration (Cmax).
Measured: predose to 96 hrs postdose
Adverse Events
Safety and tolerability measure by number of subjects who experience adverse events
Measured: up to 9 weeks
Safety Labs
Safety and tolerability measure by number of subjects who experience potential clinically significant changes in safety labs
Measured: up to 9 weeks
ECGs
Safety and tolerability measure by number of subjects who experience potential clinically significant changes in ECGs
Measured: up to 9 weeks
Vital Signs
Safety and tolerability measure by number of subjects who experience potential clinically significant changes in vital signs
Measured: up to 9 weeks
Physical Examinations
Safety and tolerability measure by number of subjects who experience potential clinically significant changes in physical exams
Measured: up to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start16 Jan 2018
- Primary completion28 Feb 2018
- Study completion9 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kirsteen Donaldson, FFPM,DM,FRCP, Study director, Corcept Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442621
- Sponsor's protocol ID
- CORT125134-123
- Status last verified
- Feb 2018
- First submitted
- 23 Jan 2018
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Single-dose, Randomized, Crossover Study in Healthy Subjects of the Effects of Co-administration With Food on Exposure, and to Determine the Within-subject Variability in Exposure, to Relacorilant and Its Metabolites
- ClinicalTrials.gov ID
- NCT03442621
- Acronym / sponsor ID
- CORT125134-123
- Conditions
- Healthy, Food-drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2018 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 9 Mar 2018 (actual)
- First posted
- 22 Feb 2018 (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.
This is an open-label, randomized, single-dose, 3-period crossover, Williams' design, food-interaction (fasted and fed arms) study conducted in healthy subjects.
Detailed description
This food-interaction study will be conducted in healthy subjects. Each subject will have a screening visit (within the 21 days prior to the first study drug administration to confirm eligibility), 3 single-dose treatment periods separated by a 7- to 14- day washout between doses, and an outpatient end-of-study follow-up visit 14 +/- 2 days after the last dose of study medication. During each treatment period, subjects will receive a single 350-mg relacorilant dose. Based on randomization to 1 of 6 sequences, each subject will receive the relacorilant dose once after a 10.5 hour fast; once 30 minutes after the start of a high-fat meal; and once 30 minutes after the start of a moderate meal.
During the first treatment period only, regardless of randomized sequence, subjects will report to the clinical research unit on the morning of Day -1 for baseline laboratory assessments and to collect samples for assay of messenger ribonucleic acid (mRNA) expression of glucocorticoid-modulated genes to explore the normal range over the day in healthy subjects. For the subsequent 2 treatment periods, subjects will report to the CRU on the evening of Day -1.
Blood samples for assay of plasma concentration of relacorilant and its main metabolites will be collected pre-dose and at 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, and 96 hours post-dose. Subjects and will remain in the clinic until after the 24-hour blood samples are collected and then be discharged and scheduled to return for the later samples.
Additional samples will be collected for possible future pharmacogenomic analysis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Relacorilant Fasted | Experimental | Drug: Relacorilant FastedRelacorilant Fasted |
| Relacorilant with a high fat breakfast | Experimental | Drug: Relacorilant with a high fat breakfastRelacorilant with a high fat breakfast |
| Relacorilant with a moderate breakfast | Experimental | Drug: Relacorilant with a moderate breakfastRelacorilant with a moderate breakfast |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Able to understand the purpose and risks of the study; willing and able to adhere to scheduled visits, treatment plans, laboratory tests, and other study evaluations and procedures.
- Give written informed consent.
- Be males or nonpregnant, nonlactating females judged to be in good health, based on the results of medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory findings.
- Have a body mass index (BMI) between 18 and 32 kg/m2, inclusive, and a body weight more than 50 kg (110 pounds).
- Be a nonsmoker. Use of nicotine or nicotine-containing products must be discontinued at least 90 days prior to the first dose of study drug.
Key exclusion criteria (22 listed)
- Be an employee or immediate family member of the Clinical Research Unit or Corcept.
- Have been previously enrolled in any study of relacorilant.
- Have multiple drug allergies, or be allergic to any of the components of relacorilant.
- Have a condition that could be aggravated by glucocorticoid blockade (eg, asthma, any chronic inflammatory condition).
- Have a history of gastric bypass surgery.
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 |
|---|---|---|
| Relacorilant FastedAlso: Relacorilant, CORT125134Relacorilant, presented as 7 x 50-mg white, hard gelatin capsules for oral administration, given following a 10.5 h fast | Drug | Relacorilant Fasted |
| Relacorilant with a high fat breakfastAlso: Relacorilant, CORT125134Relacorilant presented as 7 x 50-mg white, hard gelatin capsules for oral administration, given following a 10 h fast and 0.5 h after the start of a high fat breakfast | Drug | Relacorilant with a high fat breakfast |
| Relacorilant with a moderate breakfastAlso: Relacorilant, CORT125134Relacorilant, presented as 7 x 50-mg white, hard gelatin capsules for oral administration, given following a 10 h fast and 0.5 h after the start of a moderate breakfast | Drug | Relacorilant with a moderate breakfast |
Primary outcome
Area under plasma concentration-time curve up to the last quantifiable sample (AUC0-tz)
Time frame: predose to 96 hrs postdose
Ratio of population geometric means (GMR) for Test 1 (standard high fat breakfast) and Reference (fasted) and for Test 2 (standard moderate breakfast) and Reference for relacorilant areas under plasma concentration-time curve up to the last quantifiable sample (AUC0-tz)
7 secondary outcomes
Area under plasma concentration-time curve extrapolated to infinity (AUCinf)
Time frame: predose to 96 hrs postdose
Maximum plasma concentration (Cmax)
Time frame: predose to 96 hrs postdose
Adverse Events
Time frame: up to 9 weeks
Safety Labs
Time frame: up to 9 weeks
ECGs
Time frame: up to 9 weeks
Vital Signs
Time frame: up to 9 weeks
Physical Examinations
Time frame: up to 9 weeks
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 17 May 2018.
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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.
Kirsteen Donaldson, FFPM,DM,FRCP study director
Corcept Therapeutics
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 Relacorilant Fasted, Relacorilant with a high fat breakfast and Relacorilant with a moderate breakfast in people with Healthy and Food-drug Interaction, run by Corcept Therapeutics at 1 site in United States.
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 9 inclusion and 22 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 17 May 2018. 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 States. 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?
Area under plasma concentration-time curve up to the last quantifiable sample (AUC0-tz) (time frame: predose to 96 hrs postdose). 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 17 May 2018.