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 Details — Status: Completed

Administrative data

• NCT number: NCT00881062
• Other study ID #: ZP-009
• Status: Completed
• Phase: Phase 1
• First received: April 14, 2009
• Last updated: July 3, 2014
• Start date: April 2009
• Est. completion date: June 2009

Study information

• Verified date: July 2014
• Source: Repros Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• ABSORPTION
• EXCRETION
• METABOLISM

Intervention

Drug:
• Proellex
A single oral dose administered after at least a 10 hour fast

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit Inc.	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Repros Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the pharmacokinetics (PK) of a single dose of Proellex and its metabolites using [14C]-Proellex		14 days	No
Secondary	To characterize and identify metabolites of [14C]-Proellex in plasma and urine		14 days	No