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

Repros Therapeutics

Status and phase: Completed; Phase 1

Conditions: EXCRETION; METABOLISM; ABSORPTION

Treatments: Drug: Proellex

Study type: Interventional

Funder types: Industry

Identifiers

NCT00881062

ZP-009

Details and patient eligibility

About

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

Full 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.

Enrollment: 6 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
• Clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator
• 1 to 2 bowel movements per day.

Exclusion criteria

• Significant history or significant clinical manifestation (as determined by the Investigator) of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
• Participation in more than 1 other radiolabeled investigational study drug trial within 12 months prior to check-in
• Exposure to significant radiation (eg, serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months prior to check-in
• Donation of blood from 30 days prior to Screening through Clinic Discharge, inclusive, or of plasma from 2 weeks prior to Screening through clinic discharge, inclusive
• Receipt of blood products within 2 months prior to check-in

Trial design

6 participants in 1 patient group

25 mg Proellex

Experimental group

Description:

25 mg (100 µCi) \[14C\]-Proellex

Treatment:

Drug: Proellex