A Phase 1 interventional study of Acyline in Contraception, sponsored by University of Washington. Completed at 1 site in United States. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-12-03.
Sponsored by University of Washington · Phase 1, Interventional, and Treatment
In this study, we propose oral dosing of GIPET enhanced oral acyline (MER-104) to determine if this potentially useful compound is safe and effective at suppression of gonadotropins after oral dosing in man.
Hypothesis: A single dose of Acyline will suppress gonadotropins, and testosterone, estradiol and dihydrotestosterone (DHT) for 24 hours in man, and the magnitude and duration of the suppression will increase with increasing doses of Acyline.
The purpose of this study is to test how the body responds to a new oral form of acyline 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 given to over 100 men in an injection form. This study will be testing acyline in a pill form. This is the first time the pill form has been tested in humans.
This study may help develop an oral form of a 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 requires three 12-hour blood draw periods for pharmacokinetics (PK) testing. PK testing looks to see how much study drug is in the blood. This gives information about how the body handles and gets rid of the study drug.
University of Washington is the lead sponsor of 1,431 studies on the registry; 226 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
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Subjects will receive progressively increasing doses of 10, 20 and 40 mg of oral acyline, on 3 occasions, each separated by 1 week
Drug: Acyline
10, 20 and 40 mg of Oral acyline, given on 3 occasions, separated by 1 week.
To evaluate the suppressive effects of GIPET-enhanced oral Acyline on pituitary gonadotropin and testosterone secretion in normal men and to assess any potential side effects of GIPET enhanced oral Acyline
Time frame: 28-days
To define the pharmacokinetics of GIPET enhanced oral Acyline
Time frame: 28-days
Assess any potential side effects of GIPET enhanced oral Acyline
Time frame: 28-days
The record gives a start of Jun 2007, a primary completion of Aug 2007 and a completion of Aug 2007. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Acyline