NCT06094725

A Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Relacorilant

An Open-label, Multiple-dose, Adaptive Design Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Relacorilant

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Corcept Therapeutics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this multiple-dose, adaptive design study is to evaluate the effect of hepatic impairment on the pharmacokinetics (PK) of relacorilant relative to healthy matched control male and female subjects (Part 1).

Detailed description

If an obvious effect of moderate hepatic impairment on exposure to relacorilant is observed in Part 1, optional Part 2 of the study will be conducted. In Part 2, the effect of mild hepatic impairment on the PK of relacorilant will be evaluated, using control data from the same healthy control subjects who were matched to the subjects in Part 1. Secondary objectives of the study are 1) evaluation of the effect of hepatic impairment on the PK of relacorilant metabolites, and 2) evaluation of safety and tolerability of relacorilant on healthy subjects and those with hepatic impairment.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Relacorilant	Relacorilant 300 mg (3 X 100 mg softgel capsules) for oral administration

Timeline

• Start date: 2020-01-06
• Primary completion: 2020-12-14
• Completion: 2020-12-14
• First posted: 2023-10-23
• Last updated: 2023-10-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study