Investigate Absorption, Metabolism and Excretion of [14C}-Proellex Following Single Oral Dose in Healthy Females
Completed · Phase 1
Conditions studied: ABSORPTION, METABOLISM, EXCRETION
In brief
This study was to determine the ADME and metabolites of Proellex following a single oral dose of 25 mg.
Key facts
- Study ID
- NCT00881062
- Run by
- Repros Therapeutics Inc.
- People needed
- 6
- Starts
- 2009-04-01
- Expected to finish
- 2009-06-01
- Last updated by the study team
- 2014-07-08
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Covance Clinical Research Unit Inc. — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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