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

Healthy Clinical Trial

Official title:
A Phase 1, Randomized, Open-Label, Single-Dose, Three-Way Crossover Study to Evaluate The Effect of Food on the Oral Bioavailability of Relacorilant in Healthy Subjects

Clinical Trial 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.

Clinical Trial Description

Enrolled healthy male and female subjects will be randomized to receive 1 of 6 treatment sequences, each consisting of 3 treatments in 3 periods, in a crossover design. The 3 treatments will be a single oral dose of relacorilant 400 mg 1) under fasted conditions, 2) after a high-fat meal, and 3) after a low-fat meal. Each period will last 5 days, and a 7-day washout will follow Periods 1 and 2. Blood samples will be collected predose and at serial timepoints up to 4 days (Day 5) after dosing in each period for evaluation of the bioavailability of relacorilant. Secondary objectives of the study will be evaluation of the bioavailability of relacorilant metabolites, and evaluation of safety and tolerability of relacorilant when administered to healthy subjects under fasted and fed conditions. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06094738
Study type Interventional
Source Corcept Therapeutics
Contact
Status Completed
Phase Phase 1
Start date September 19, 2020
Completion date November 16, 2020
View Details
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