Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06094738 | A Study to Evaluate the Effect of Food on the Oral Bioavailability of Relacorilant in Healthy Subjects | PHASE1 | COMPLETED | 30 | — | — | Sep 19, 2020 | Nov 16, 2020 | Oct 23, 2023 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| Relacorilant under fasted conditions | DRUG | Oral relacorilant 400 mg (4 X 100 mg softgel capsules) single dose on Day 1 under fasted conditions |
| 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 |
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...