Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


NCT number NCT00741273
Study type Interventional
Source Repros Therapeutics Inc.
Contact
Status Completed
Phase Phase 1
Start date October 2008
Completion date June 2009

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03767803 - Collection of Whole Blood Samples for the Evaluation of Preeclampsia (Pre-E) Biomarkers From Pregnant Women
Withdrawn NCT05084456 - Oral Docetaxel in Patients With Normal or Impaired Liver Function Phase 1
Completed NCT02780414 - Collection of Samples From Pregnant Women for the Evaluation of Preeclampsia (Pre-E) Biomarkers
Completed NCT02010034 - Compassionate Use of Omegaven in the Treatment of Parenteral Nutrition Induced Hepatic Injury N/A