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Sponsors and Collaborators: |
University of Washington Merrion Pharmaceuticals, LLC |
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Information provided by: | University of Washington |
ClinicalTrials.gov Identifier: | NCT00603187 |
We propose oral dosing of GIPET enhanced oral acyline at 20 mg everyday for one week to determine the steady-state (multiple-dose) pharmacokinetics of oral acyline in four normal, healthy young men.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Acyline |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Pharmacokinetics Study |
Official Title: | Oral Administration of the GnRH Antagonist Acyline in Normal Men Part II: Multiple-Dose Pharmacokinetics (Acyline-7/MER 104-02) |
Estimated Enrollment: | 4 |
Study Start Date: | January 2008 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
20 mg dose of GIPET enhanced oral acyline for 7 days
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Drug: Acyline
20 mg oral dose, daily for 7-days
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The purpose of this study is to test how the body responds to a new oral form of acyline given for seven days and to also look at the safety of oral acyline.
Acyline temporarily blocks the production of the hormone testosterone in normal men. It has been tested in over 100 men in an injection form. This study will be testing acyline in a pill form for seven days.
This study may help develop an oral form of testosterone-blocker which may be useful in the treatment of diseases such as prostate cancer, premature puberty and possibly in a male contraceptive.
This study will evaluate a single dose of oral acyline given once a day for seven days.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Washington | |
University of Washington | |
Seattle, Washington, United States, 98195 |
Principal Investigator: | John K Amory, MD, MPH | University of Washington |
Responsible Party: | University of Washington ( John K Amory, MD, MPH ) |
Study ID Numbers: | 07-7973-W |
Study First Received: | January 15, 2008 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00603187 |
Health Authority: | United States: Food and Drug Administration |
Male Contraception Acyline |
Healthy |