drugset / Trial / NCT03457597

Study in Healthy Subjects to Determine the Effect of Relacorilant on Exposure to Probe Substrates for Cytochrome P450s

NCT03457597

Phase 1 Completed 27 enrolled Corcept Therapeutics
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

EvaluationDrugModalityDoseRoute
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.