A Phase 1, Randomized, Open-Label, Single-Dose, Three-Way Crossover Study to Evaluate The Effect of Food on the Oral Bioavailability of Relacorilant in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- Relacorilant under fasted conditions
- Conditions
- Healthy
- Sponsor
- Corcept Therapeutics
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Maximal observed concentration of plasma relacorilant (Cmax)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The primary objective of the study is to evaluate the effects of a high-fat meal and of a low-fat meal on the bioavailability of relacorilant in healthy subjects.
Detailed Description
Enrolled healthy male and female subjects will be randomized to receive 1 of 6 treatment sequences, each consisting of 3 treatments in 3 periods, in a crossover design. The 3 treatments will be a single oral dose of relacorilant 400 mg 1) under fasted conditions, 2) after a high-fat meal, and 3) after a low-fat meal. Each period will last 5 days, and a 7-day washout will follow Periods 1 and 2. Blood samples will be collected predose and at serial timepoints up to 4 days (Day 5) after dosing in each period for evaluation of the bioavailability of relacorilant. Secondary objectives of the study will be evaluation of the bioavailability of relacorilant metabolites, and evaluation of safety and tolerability of relacorilant when administered to healthy subjects under fasted and fed conditions.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Body mass index \>18.5 and \<30.0 kg/m\^2 and body weight ≥50.0 kg for male subjects and ≥45.0 kg for female subjects
- •Healthy, as defined by the absence of clinically significant illness and/or surgery within 4 weeks prior to dosing, and the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease
- •Female subjects of childbearing potential who are sexually active with a non-sterile male partner must be willing to use an acceptable contraceptive method as defined in the protocol, throughout the study.
- •Male subjects who are not vasectomized for at least 6 months, and who are sexually active with a female partner of childbearing potential must be willing to use an acceptable contraceptive method as defined in the protocol, from the first study drug administration until at least 90 days after the last study drug administration
- •Male subjects must be willing not to donate sperm until 90 days following the last study drug administration.
- •Capable of, and have given, written informed consent
- •Willing to consume a high-fat breakfast, including pork
- •Able to and willing to fast for any laboratory evaluations.
Exclusion Criteria
- •Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for HIV, hepatitis B, or hepatitis C
- •Female subject with a positive pregnancy test at Screening
- •Male subject with a pregnant partner at Screening
- •Positive urine drug screen or urine cotinine test or alcohol breath test at Screening
- •History of allergic reactions to relacorilant or other related drugs, or to any excipient in the formulation
- •Clinically significant electrocardiogram abnormalities or vital sign abnormalities at Screening
- •History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit (more than 14 units of alcohol per week \[1 unit = 83 mL of wine 12%, 200 mL of beer 5%, or 25 mL of alcohol 40%\])
- •History of significant drug abuse within 1 year prior to Screening or use of soft drugs within 3 months prior to Screening or hard drugs within 1 year of Screening
- •Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration
- •Use of medications for the timeframes specified in the protocol, with the exception of acceptable hormonal contraceptives and medications exempted by the Investigator, with agreement by the Sponsor because they are judged unlikely to affect the pharmacokinetic profile of the study drug or subject safety
Arms & Interventions
Relacorilant under fasted conditions
Subjects will receive oral relacorilant 400 mg (4 X 100 mg softgel capsules) single dose on Day 1 under fasted conditions. The study period in which a subject will receive this treatment will be determined by random assignment to 1 of 6 treatment sequences.
Intervention: Relacorilant under fasted conditions
Relacorilant after a high-fat meal
Subjects will receive oral relacorilant 400 mg (4 X 100 mg softgel capsules) single dose on Day 1 after a high-fat meal. The study period in which a subject will receive this treatment will be determined by random assignment to 1 of 6 treatment sequences.
Intervention: Relacorilant after a high-fat meal
Relacorilant after a low-fat meal
Subjects will receive oral relacorilant 400 mg (4 X 100 mg softgel capsules) single dose on Day 1 after a low-fat meal. The study period in which a subject will receive this treatment will be determined by random assignment to 1 of 6 treatment sequences.
Intervention: Relacorilant after a low-fat meal
Outcomes
Primary Outcomes
Maximal observed concentration of plasma relacorilant (Cmax)
Time Frame: Predose and at serial timepoints up to 4 days (Day 5) after dosing on Day 1
Area under the concentration-time curve from time zero extrapolated to infinity of plasma relacorilant (AUC0-inf)
Time Frame: Predose and at serial timepoints up to 4 days (Day 5) after dosing on Day 1
Area under the concentration-time curve from time zero to the last observed concentration of plasma relacorilant (AUC0-t)
Time Frame: Predose and at serial timepoints up to 4 days (Day 5) after dosing on Day 1
Secondary Outcomes
- Cmax of relacorilant plasma metabolites(Predose and at serial timepoints up to 4 days (Day 5) after dosing on Day 1)
- Number of subjects with one or more adverse events(Up to Day 28)
- AUC0-inf of relacorilant plasma metabolites(Predose and at serial timepoints up to 4 days (Day 5) after dosing on Day 1)
- AUC0-t of relacorilant plasma metabolites(Predose and at serial timepoints up to 4 days (Day 5) after dosing on Day 1)
- Number of subjects with one or more serious adverse events(Up to Day 55)
- Number of subjects with one or more adverse events leading to study drug discontinuation(Up to Day 25)