ABSORPTION, EXCRETION, METABOLISM
Conditions
Keywords
ABSORPTION, METABOLISM, EXCRETION
Brief summary
This study was to determine the ADME and metabolites of Proellex following a single oral dose of 25 mg.
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.
Interventions
DRUGProellex
A single oral dose administered after at least a 10 hour fast
Sponsors
Repros Therapeutics Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the pharmacokinetics (PK) of a single dose of Proellex and its metabolites using [14C]-Proellex | 14 days |
Secondary
| Measure | Time frame |
|---|---|
| To characterize and identify metabolites of [14C]-Proellex in plasma and urine | 14 days |
Countries
United States
Outcome results
None listed