CClinicalTrials.gg
CompletedNCT00881062Updated Jul 8, 2014

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

A Phase 1 interventional study of Proellex in ABSORPTION, METABOLISM and EXCRETION, sponsored by Repros Therapeutics Inc.. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-08.

Sponsored by Repros Therapeutics Inc. · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • ABSORPTION
  • METABOLISM
  • EXCRETION

Keywords

  • ABSORPTION
  • METABOLISM
  • EXCRETION
03

In context

Lead sponsor

Repros Therapeutics Inc. is the lead sponsor of 57 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts 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

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
05

Study design

Phase
Phase 1
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    25 mg Proellex

    25 mg (100 µCi) \[14C\]-Proellex

    Drug: Proellex

Interventions

  • DrugProellex

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

    Also known as: Telapristone acetate

06

What researchers measure

Primary outcomes

  1. To assess the pharmacokinetics (PK) of a single dose of Proellex and its metabolites using [14C]-Proellex

    Time frame: 14 days

Secondary outcomes

  1. To characterize and identify metabolites of [14C]-Proellex in plasma and urine

    Time frame: 14 days

07

Study locations

1 site
  • Covance Clinical Research Unit Inc.
    Madison, Wisconsin 53704, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00881062
Lead sponsor
Repros Therapeutics Inc.
Responsible party
Sponsor
First posted
Apr 15, 2009
Start date
Apr 2009
Primary completion
May 2009
Completion
Jun 2009
Last update
Jul 8, 2014

Study contacts

Andre van As, MD, PhD
study director · Repros Therapeutics Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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