Relacorilant Food Effect Study in Healthy Subjects

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Corcept Therapeutics
Study ID
NCT03442621
Phase
PHASE1
Status
Completed

Conditions

  • Food-drug Interaction
  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Relacorilant Fasted — DRUG
    Relacorilant, presented as 7 x 50-mg white, hard gelatin capsules for oral administration, given following a 10.5 h fast
  • Relacorilant with a high fat breakfast — DRUG
    Relacorilant presented as 7 x 50-mg white, hard gelatin capsules for oral administration, given following a 10 h fast and 0.5 h after the start of a high fat breakfast
  • Relacorilant with a moderate breakfast — DRUG
    Relacorilant, presented as 7 x 50-mg white, hard gelatin capsules for oral administration, given following a 10 h fast and 0.5 h after the start of a moderate breakfast

Study Details

This is an open-label, randomized, single-dose, 3-period crossover, Williams' design, food-interaction (fasted and fed arms) study conducted in healthy subjects.

Key Dates

First listed
Feb 22, 2018
Start date
Jan 16, 2018
Status verified
Feb 2018
Primary completion
Feb 28, 2018
Completion
Mar 9, 2018

Study Design

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

Arms

  • Experimental: Relacorilant Fasted
    Relacorilant Fasted
  • Experimental: Relacorilant with a high fat breakfast
    Relacorilant with a high fat breakfast
  • Experimental: Relacorilant with a moderate breakfast
    Relacorilant with a moderate breakfast

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-

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By research site
Celerion· Tempe, AZ

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