NCT06928779

Effects of Hepatic Impairment on the Pharmacokinetics of Dazucorilant

An Open-Label, Single-Dose, Adaptive Design Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Dazucorilant

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Corcept Therapeutics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study will compare the pharmacokinetics (PK) of dazucorilant (CORT113176) between participants with normal hepatic function and participants with hepatic impairment.

Detailed description

Initially, participants with moderate hepatic impairment and healthy control participants matched as to gender, age, and weight will be enrolled. After completing screening assessments, participants will receive a single dose of dazucorilant followed by an observation period of 7 days. Based on the observed effect of moderate hepatic impairment on the dazucorilant PK profile, and review of safety data, a group of participants with mild hepatic impairment, matched to the enrolled healthy control participants, may be enrolled to evaluate the effects of mild hepatic impairment on dazucorilant PK.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Dazucorilant	Dazucorilant 300 mg (4 X 75 mg) soft gelatin capsules for oral administration

Timeline

• Start date: 2024-10-08
• Primary completion: 2024-12-09
• Completion: 2024-12-09
• First posted: 2025-04-15
• Last updated: 2025-04-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study