NCT06094738

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Corcept Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-09-19
• Primary completion: 2020-11-16
• Completion: 2020-11-16
• First posted: 2023-10-23
• Last updated: 2023-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study