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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00881062
First received: April 14, 2009
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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


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

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: 25 mg Proellex
25 mg (100 µCi) [14C]-Proellex
Drug: Proellex
A single oral dose administered after at least a 10 hour fast
Other Name: Telapristone acetate

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 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00881062     History of Changes
Other Study ID Numbers: ZP-009
Study First Received: April 14, 2009
Last Updated: July 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Repros Therapeutics Inc.:
ABSORPTION
METABOLISM
EXCRETION

ClinicalTrials.gov processed this record on October 23, 2014