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

NCT06094738 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-10-23

No results posted yet for this study

Summary

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.

Conditions

  • Healthy

Interventions

DRUG

Relacorilant under fasted conditions

Oral relacorilant 400 mg (4 X 100 mg softgel capsules) single dose on Day 1 under fasted conditions

DRUG

Relacorilant after a high-fat meal

Oral relacorilant 400 mg (4 X 100 mg softgel capsules) single dose on Day 1 after a high-fat meal

DRUG

Relacorilant after a low-fat meal

Oral relacorilant 400 mg (4 X 100 mg softgel capsules) single dose on Day 1 after a low-fat meal

Sponsors & Collaborators

  • Corcept Therapeutics

    lead INDUSTRY

Principal Investigators

  • Joseph Custodio · 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
2020-09-19
Primary Completion
2020-11-16
Completion
2020-11-16
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 NCT06094738 on ClinicalTrials.gov