NCT00741273

Evaluate the Safety and PK of Proellex® in Female Patients With Impaired Hepatic Function and Healthy Adults

An Open-label, Two-stage, Dose-escalation, Parallel Group Study to Evaluate the Safety and Pharmacokinetics Profile of Proellex® (CDB-4124) in Female Patients With Impaired Hepatic Function and Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Female
• Age: 18 Years – 62 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety and pharmacokinetics of two doses of orally administered Proellex® in female patients with impaired hepatic function and healthy volunteers with normal hepatic function.

Detailed description

16 subjects will be allocated to 2 groups. The test group will consist of 8 female patients with moderately impaired hepatic function meeting the Child-Pugh Class B severity criteria, while the control group will consist of 8 healthy female adult volunteers. During Stage I, all subjects will receive a single oral dose of 25mg of Proellex® (fasting state) and be followed in a Clinical Research Unit (CRU) for about three days. Only subjects who do not experience serious adverse events (SAEs) or adverse events (AEs) that are determined by Investigator to be possibly, probably or definitely related to the treatment will participate in Stage II. The dose will be increased to a single dose of 50mg of Proellex® (fasting state) and subjects will be followed in a Clinical Research Unit (CRU) for about three days. Subjects will undergo blood draws at several time points.

Conditions

• Impaired Liver Function

Interventions

Type	Name	Description
DRUG	Proellex	Proellex 25 mg capsule, single dose

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-05-01
• Completion: 2009-06-01
• First posted: 2008-08-26
• Last updated: 2014-08-28
• Results posted: 2014-08-28

Locations

2 sites across 1 country: United States