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Investigate Absorption, Metabolism and Excretion of [14C}-Proellex Following Single Oral Dose in Healthy Females

METABOLISM Clinical Trial

Official title:
A Phase 1 Study to Investigate the Absorption, Metabolism and Excretion of [14C}-Proellex Following Single Oral Dose Administration in Healthy Female Subjects

Clinical Trial Summary

This study was to determine the ADME and metabolites of Proellex following a single oral dose of 25 mg.

Clinical Trial Description

The purpose of this study is to determine the absorption, metabolism, and excretion kinetics of Proellex and to determine and characterize metabolites present in plasma and urine following a single oral dose of 25 mg. The 25 mg dose selected for this study has been included in all previous clinical trials. This dose was well tolerated and demonstrated efficacy against uterine fibroids and endometriosis. ;

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00881062
Study type Interventional
Source Repros Therapeutics Inc.
Contact
Status Completed
Phase Phase 1
Start date April 2009
Completion date June 2009
View Details
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