A Study to Evaluate the Effect of Food on the Oral Bioavailability of Relacorilant in Healthy Subjects

Part of paid clinical trials in Miami, Florida.

Sponsor
Corcept Therapeutics
Study ID
NCT06094738
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The primary objective of the study is to evaluate the effects of a high-fat meal and of a low-fat meal on the bioavailability of relacorilant in healthy subjects.

Key Dates

First listed
Oct 23, 2023
Start date
Sep 19, 2020
Status verified
Oct 2023
Primary completion
Nov 16, 2020
Completion
Nov 16, 2020

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Relacorilant under fasted conditions
    Subjects will receive oral relacorilant 400 mg (4 X 100 mg softgel capsules) single dose on Day 1 under fasted conditions. The study period in which a subject will receive this treatment will be determined by random assignment to 1 of 6 treatment sequences.
  • Experimental: Relacorilant after a high-fat meal
    Subjects will receive oral relacorilant 400 mg (4 X 100 mg softgel capsules) single dose on Day 1 after a high-fat meal. The study period in which a subject will receive this treatment will be determined by random assignment to 1 of 6 treatment sequences.
  • Experimental: Relacorilant after a low-fat meal
    Subjects will receive oral relacorilant 400 mg (4 X 100 mg softgel capsules) single dose on Day 1 after a low-fat meal. The study period in which a subject will receive this treatment will be determined by random assignment to 1 of 6 treatment sequences.

Primary Outcome Measure

Area under the concentration-time curve from time zero to the last observed concentration of plasma relacorilant (AUC0-t) [ Time Frame: Predose and at serial timepoints up to 4 days (Day 5) after dosing on Day 1 ]

Locations (1)

FacilityCityStateZIPSite coordinators
inVentiv Health Clinical Research Services LLCMiamiFlorida33136-

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By research site
inVentiv Health Clinical Research Services LLC· Miami, FL

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