ACY-6 Oral Administration of Acyline

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Oral Administration of the GnRH Antagonist Acyline in Normal Men

Conditions
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Contraception

Intervention / Treatment
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* Drug: Acyline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>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<br>* 10, 20 and 40 mg of Oral acyline, given on 3 occasions, separated by 1 week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 28-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To define the pharmacokinetics of GIPET enhanced oral Acyline |  | 28-days | 
| Assess any potential side effects of GIPET enhanced oral Acyline |  | 28-days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Male Contraception, Acyline