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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03442621 | Relacorilant Food Effect Study in Healthy Subjects | PHASE1 | COMPLETED | 30 | — | — | Jan 16, 2018 | Mar 9, 2018 | May 17, 2018 | 1 | United States |
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)
| Arm | Type | Description |
|---|---|---|
| Relacorilant Fasted | EXPERIMENTAL | Relacorilant Fasted |
| Relacorilant with a high fat breakfast | EXPERIMENTAL | Relacorilant with a high fat breakfast |
| Relacorilant with a moderate breakfast | EXPERIMENTAL | Relacorilant with a moderate breakfast |
| Name | Type | Description |
|---|---|---|
| Relacorilant Fasted | DRUG | 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 breakfast | DRUG | 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 breakfast | DRUG | 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 |
Inclusion Criteria: 1. 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. 2. Give written informed consent. 3. Be males or nonpregnant, nonlactating females judged to b...