drugset / Trial / NCT03457597
Study in Healthy Subjects to Determine the Effect of Relacorilant on Exposure to Probe Substrates for Cytochrome P450s
Non-randomizedCrossoverOpen-labelOther
Summary
This is an open-label, single-sequence, 3-period crossover study conducted in healthy subjects. Eligible subjects will participate in a single treatment period, in which they will receive the following treatments: Day 1, single doses of midazolam and metoprolol; Day 2, single doses of pioglitazone, tolbutamide, and omeprazole; Days 5 to 17, daily doses of relacorilant; Day 14, single doses of midazolam and metoprolol (with relacorilant); and, Day 15, single doses of pioglitazone, tolbutamide, and omeprazole (with relacorilant).
Timeline
- Start
- 2018-03-06
- Primary completion
- 2018-04-15
- Completion
- 2018-04-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metoprolol | Other / unclassified | 100 mg | — |
| Subject | Midazolam | Small molecule | 2.5 mg | — |
| Subject | Omeprazole | Other / unclassified | 20 mg | — |
| Subject | Pioglitazone | Small molecule | 15 mg | — |
| Subject | Relacorilant | Small molecule | 350 mg | — |
| Subject | Tolbutamide | Small molecule | 500 mg | — |
Indications
No indication recorded.