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

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Corcept Therapeutics
Study ID
NCT03457597
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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).

Key Dates

First listed
Mar 7, 2018
Start date
Mar 6, 2018
Status verified
Feb 2018
Primary completion
Apr 15, 2018
Completion
Apr 28, 2018

Study Design

Enrollment
27 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Period 1
    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
  • Experimental: Period 2
    Period 2 (Study Days 5 to 13): Relacorilant will be given daily from Day 5 to Day 13.
  • Experimental: Period 3
    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.

Primary Outcome Measure

Area under plasma concentration-time curve up to the last quantifiable sample (AUC0-tz) [ Time Frame: predose to 96 hrs postdose ]

Locations (1)

FacilityCityStateZIPSite coordinators
CelerionTempeArizona85283-

Find similar trials in Tempe, AZ

By research site
Celerion· Tempe, AZ

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