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.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
6
A single oral dose administered after at least a 10 hour fast
Covance Clinical Research Unit Inc.
Madison, Wisconsin, United States
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
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