Status:
COMPLETED
Investigate Absorption, Metabolism and Excretion of [14C}-Proellex Following Single Oral Dose in Healthy Females
Lead Sponsor:
Repros Therapeutics Inc.
Conditions:
ABSORPTION
METABOLISM
Eligibility:
FEMALE
18-50 years
Phase:
PHASE1
Brief 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 or...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00881062
Start Date
April 1 2009
End Date
June 1 2009
Last Update
July 8 2014
Active Locations (1)
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1
Covance Clinical Research Unit Inc.
Madison, Wisconsin, United States, 53704