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
This study was to determine the ADME and metabolites of Proellex following a single oral dose of 25 mg.
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.
Repros Therapeutics Inc. is the lead sponsor of 57 studies on the registry; none are open to participants now.
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Exclusion Criteria:
25 mg (100 µCi) \[14C\]-Proellex
Drug: Proellex
A single oral dose administered after at least a 10 hour fast
Also known as: Telapristone acetate
To assess the pharmacokinetics (PK) of a single dose of Proellex and its metabolites using [14C]-Proellex
Time frame: 14 days
To characterize and identify metabolites of [14C]-Proellex in plasma and urine
Time frame: 14 days
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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Repros Therapeutics Inc.