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Relacorilant Food Effect Study in Healthy Subjects

NCT03442621 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-05-17

No results posted yet for this study

Summary

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

Conditions

  • Healthy
  • Food-drug Interaction

Interventions

DRUG

Relacorilant Fasted

Relacorilant, presented as 7 x 50-mg white, hard gelatin capsules for oral administration, given following a 10.5 h fast

DRUG

Relacorilant with a high fat breakfast

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

DRUG

Relacorilant with a moderate breakfast

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

Sponsors & Collaborators

  • Corcept Therapeutics

    lead INDUSTRY

Principal Investigators

  • Kirsteen Donaldson, FFPM,DM,FRCP · Corcept Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-16
Primary Completion
2018-02-28
Completion
2018-03-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03442621 on ClinicalTrials.gov