ACY-6 Oral Administration of Acyline

Phase 1

Completed

• Conditions: Contraception
• Interventions: Drug: Acyline

• Registration Number: NCT00471185
• Lead Sponsor: University of Washington

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2007-05-07
• Study First Submitted QC: 2007-05-08
• Study First Posted: 2007-05-09
• Study Start: 2007-06
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-02
• Last Update Posted: 2010-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Acyline	Subjects will receive progressively increasing doses of 10, 20 and 40 mg of oral acyline, on 3 occasions, each separated by 1 week

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To define the pharmacokinetics of GIPET enhanced oral Acyline	28-days
Assess any potential side effects of GIPET enhanced oral Acyline	28-days

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States