Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06094738
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2023-10-17
Brief Title:
A Study to Evaluate the Effect of Food on the Oral Bioavailability of Relacorilant in Healthy Subjects
Sponsor:
Corcept Therapeutics
Organization:
Corcept Therapeutics
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None