Investigate Absorption, Metabolism and Excretion of [14C}-Proellex Following Single Oral Dose in Healthy Females
Summary
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 Design
Control: Active Control, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Conditions
Absorption
Intervention
Proellex
Location
Covance Clinical Research Unit Inc.
Madison
Wisconsin
United States
53704
Status
Completed
Source
Repros Therapeutics Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00881062
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Pharmacokinetics
Dynamic and kinetic mechanisms of exogenous chemical and drug ABSORPTION; BIOLOGICAL TRANSPORT; TISSUE DISTRIBUTION; BIOTRANSFORMATION; elimination; and TOXICOLOGY as a function of dosage, and rate of METABOLISM. It includes toxicokinetics, the pharmacokinetic mechanism of the toxic effects of a substance. ADME and ADMET are short-hand abbreviations for absorption, distribution, metabolism, elimination and toxicology.
Intestinal Absorption
Uptake of substances through the lining of the INTESTINES.
Photolysis
Chemical bond cleavage reactions resulting from absorption of radiant energy.
Color
The visually perceived property of objects created by absorption or reflection of specific wavelengths of light.
Steatorrhea
A condition that is characterized by chronic fatty DIARRHEA, a result of abnormal DIGESTION and/or INTESTINAL ABSORPTION of FATS.
Clinical Trials
Study to Evaluate Menses Induction in Women Administered Proellex
The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able induce menstruation.
Proellex Pharmacokinetics Bridging Study
Healthy female subjects received a single dose of four different types of Proellex, the original 25 mg dose and three new formulations (24 and 50 mg dose). Blood was collected pre-dose, at...
The study is intended to provide more abundant safety and efficacy data of both the 25 and 50 mg doses of Proellex than ZPU-301, ZPU-302, ZPU-303 and ZPU-304 alone.
The primary objective is to evaluate the pharmacokinetics (PK) of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.
Proellex® Pharmacokinetic Bridging Study II
This is an open-label, randomized, single-center, outpatient, unblinded, single-dose, three-way crossover study of the safety and PK properties of Proellex® in women ages 18 - 34 years. T...
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