NCT00881062

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• ABSORPTION
• METABOLISM
• EXCRETION

Interventions

Type	Name	Description
DRUG	Proellex	A single oral dose administered after at least a 10 hour fast

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-05-01
• Completion: 2009-06-01
• First posted: 2009-04-15
• Last updated: 2014-07-08

Locations

1 site across 1 country: United States