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

Study Overview
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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.

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.

Official Title
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A Phase 1 Study to Investigate the Absorption, Metabolism and Excretion of [14C}-Proellex Following Single Oral Dose Administration in Healthy Female Subjects

Conditions
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ABSORPTION, METABOLISM, EXCRETION

Intervention / Treatment
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* Drug: Proellex


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 25 mg Proellex<br>25 mg (100 µCi) [14C]-Proellex | Drug: Proellex<br>* A single oral dose administered after at least a 10 hour fast<br>* Other names: Telapristone acetate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the pharmacokinetics (PK) of a single dose of Proellex and its metabolites using [14C]-Proellex |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize and identify metabolites of [14C]-Proellex in plasma and urine |  | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ABSORPTION, METABOLISM, EXCRETION