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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03457597 | Study in Healthy Subjects to Determine the Effect of Relacorilant on Exposure to Probe Substrates for Cytochrome P450s | PHASE1 | COMPLETED | 27 | — | — | Mar 6, 2018 | Apr 28, 2018 | May 17, 2018 | 1 | United States |
Ratio of population geometric means (GMR) for Reference Day (following a single dose with each probe substrate given within a cocktail of probe substrates) and Test Day (following the same dose given to subjects after 10 or 11 days of daily dosing with relacorilant) areas under plasma concentration-time curve up to the last quantifiable sample (AUC0-tz)
| Arm | Type | Description |
|---|---|---|
| Period 1 | EXPERIMENTAL | Period 1 (Study Days 1 to 4): Midazolam hydrochloride and metoprolol tartrate will be given once on Day 1. Pioglitazone hydrochloride, tolbutamide and omeprazole will be given once on Day 2 |
| Period 2 | EXPERIMENTAL | Period 2 (Study Days 5 to 13): Relacorilant will be given daily from Day 5 to Day 13. |
| Period 3 | EXPERIMENTAL | Period 3 (Study Days 14 to 17): Midazolam hydrochloride and metoprolol tartrate will be given once on Day 14. Pioglitazone hydrochloride, tolbutamide and omeprazole will be given once on Day 15. Relacorilant will be given daily from Day 14 to Day 17. |
| Name | Type | Description |
|---|---|---|
| Midazolam hydrochloride | DRUG | Midazolam hydrochloride 2.5 mg |
| Metoprolol tartrate | DRUG | Metoprolol tartrate 100 mg |
| Pioglitazone hydrochloride | DRUG | Pioglitazone hydrochloride 15 mg |
| Tolbutamide | DRUG | Tolbutamide 500 mg |
| Omeprazole | DRUG | Omeprazole 20 mg |
| Relacorilant | DRUG | Relacorilant 350mg |
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...