ACY-6 Oral Administration of Acyline
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Contraception |
Drug: Acyline |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Oral Administration of the GnRH Antagonist Acyline in Normal Men |
- 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 ] [ Designated as safety issue: No ]
- To define the pharmacokinetics of GIPET enhanced oral Acyline [ Time Frame: 28-days ] [ Designated as safety issue: No ]
- Assess any potential side effects of GIPET enhanced oral Acyline [ Time Frame: 28-days ] [ Designated as safety issue: Yes ]
| Enrollment: | 9 |
| Study Start Date: | June 2007 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
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.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Males between 18-50 years of Age in good health
Exclusion Criteria:
- Men in poor health, significant chronic or acute medical illness, known history of alcohol, illicit drug or anabolic steroid abuse
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00471185
| United States, Washington | |
| University of Washington | |
| Seattle, Washington, United States, 98195 | |
| Principal Investigator: | John K Amory | University of Washington |
More Information
Additional Information:
Publications:
| Responsible Party: | John K Amory, MD, MPH, University of Washington |
| ClinicalTrials.gov Identifier: | NCT00471185 History of Changes |
| Other Study ID Numbers: | 31511-W, 07-4947-W 02 |
| Study First Received: | May 7, 2007 |
| Last Updated: | December 2, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Washington:
|
Male Contraception Acyline |
ClinicalTrials.gov processed this record on March 01, 2015