Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relacorilant under fasted conditions | Experimental | 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. |
|
| Relacorilant after a high-fat meal | Experimental | 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. |
|
| Relacorilant after a low-fat meal | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relacorilant under fasted conditions | Drug | Oral relacorilant 400 mg (4 X 100 mg softgel capsules) single dose on Day 1 under fasted conditions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from time zero to the last observed concentration of plasma relacorilant (AUC0-t) | 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) | Predose and at serial timepoints up to 4 days (Day 5) after dosing on Day 1 | |
| Maximal observed concentration of plasma relacorilant (Cmax) | Predose and at serial timepoints up to 4 days (Day 5) after dosing on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t of relacorilant plasma metabolites | Predose and at serial timepoints up to 4 days (Day 5) after dosing on Day 1 | |
| AUC0-inf of relacorilant plasma metabolites | Predose and at serial timepoints up to 4 days (Day 5) after dosing on Day 1 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joseph Custodio | Corcept Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| inVentiv Health Clinical Research Services LLC | Miami | Florida | 33136 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000633444 | relacorilant |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Relacorilant after a high-fat meal | Drug | Oral relacorilant 400 mg (4 X 100 mg softgel capsules) single dose on Day 1 after a high-fat meal |
|
|
| Relacorilant after a low-fat meal | Drug | Oral relacorilant 400 mg (4 X 100 mg softgel capsules) single dose on Day 1 after a low-fat meal |
|
|
| 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 |
| 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 |