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

This study has been completed.
Sponsor:
Information provided by:
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00881062
First received: April 14, 2009
Last updated: February 10, 2010
Last verified: February 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Absorption
Metabolism
Excretion
 Drug: Proellex
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:
  • To assess the pharmacokinetics (PK) of a single dose of Proellex and its metabolites using [14C]-Proellex [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To characterize and identify metabolites of [14C]-Proellex in plasma and urine [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: April 2009
Study Completion Date: June 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
25 mg (100 µCi) [14C]-Proellex
 Drug: Proellex
A single oral dose administered after at least a 10 hour fast

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00881062

Locations
United States, Wisconsin
Covance Clinical Research Unit Inc.
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Repros Therapeutics Inc.
Investigators
Study Director: Andre van As, MD, PhD Repros Therapeutics Inc.
  More Information

No publications provided

Responsible Party: Ronald Wiehle, MD, Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00881062     History of Changes
Other Study ID Numbers: ZP-009
Study First Received: April 14, 2009
Last Updated: February 10, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Repros Therapeutics Inc.:
ABSORPTION
METABOLISM
EXCRETION

ClinicalTrials.gov processed this record on May 23, 2013