Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Repros Therapeutics Inc. |
---|---|
Information provided by: | Repros Therapeutics Inc. |
ClinicalTrials.gov Identifier: | NCT00881062 |
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.
Condition | Intervention | Phase |
---|---|---|
Absorption Metabolism Excretion |
Drug: Proellex |
Phase I |
Study Type: | Interventional |
Study Design: | Open Label, Active Control, Single Group Assignment, Pharmacokinetics Study |
Official Title: | A Phase 1 Study to Investigate the Absorption, Metabolism and Excretion of [14C}-Proellex Following Single Oral Dose Administration in Healthy Female Subjects |
Estimated Enrollment: | 6 |
Study Start Date: | April 2009 |
Study Completion Date: | June 2009 |
Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
25 mg (100 µCi) [14C]-Proellex
|
Drug: Proellex
A single oral dose administered after at least a 10 hour fast
|
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Wisconsin | |
Covance Clinical Research Unit Inc. | |
Madison, Wisconsin, United States, 53704 |
Study Director: | Andre van As, MD, PhD | Repros Therapeutics Inc. |
Responsible Party: | Repros Therapeutics Inc. ( Ronald Wiehle, MD ) |
Study ID Numbers: | ZP-009 |
Study First Received: | April 14, 2009 |
Last Updated: | July 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00881062 History of Changes |
Health Authority: | United States: Food and Drug Administration |
ABSORPTION METABOLISM EXCRETION |
Healthy |