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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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ABSORPTION METABOLISM EXCRETION

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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25 mg Proellex

25 mg (100 µCi) \[14C\]-Proellex

Group Type EXPERIMENTAL

Proellex

Intervention Type DRUG

A single oral dose administered after at least a 10 hour fast

Interventions

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Proellex

A single oral dose administered after at least a 10 hour fast

Intervention Type DRUG

Other Intervention Names

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Telapristone acetate

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes