Investigate Absorption, Metabolism and Excretion of [14C}-Proellex Following Single Oral Dose in Healthy Females
A Phase 1 Study to Investigate the Absorption, Metabolism and Excretion of [14C}-Proellex Following Single Oral Dose Administration in Healthy Female Subjects
1 other identifier
interventional
6
1 country
1
Brief Summary
This study was to determine the ADME and metabolites of Proellex following a single oral dose of 25 mg.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2009
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 14, 2009
CompletedFirst Posted
Study publicly available on registry
April 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedJuly 8, 2014
July 1, 2014
1 month
April 14, 2009
July 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the pharmacokinetics (PK) of a single dose of Proellex and its metabolites using [14C]-Proellex
14 days
Secondary Outcomes (1)
To characterize and identify metabolites of [14C]-Proellex in plasma and urine
14 days
Study Arms (1)
25 mg Proellex
EXPERIMENTAL25 mg (100 µCi) \[14C\]-Proellex
Interventions
A single oral dose administered after at least a 10 hour fast
Eligibility Criteria
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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Covance Clinical Research Unit Inc.
Madison, Wisconsin, 53704, United States
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Andre van As, MD, PhD
Repros Therapeutics Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2009
First Posted
April 15, 2009
Study Start
April 1, 2009
Primary Completion
May 1, 2009
Study Completion
June 1, 2009
Last Updated
July 8, 2014
Record last verified: 2014-07