Skip to main content
OpenTrials
Completed

NCT Number: NCT00471185

ACY-6 Oral Administration of Acyline

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Contraception

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acyline

Drug

10, 20 and 40 mg of Oral acyline, given on 3 occasions, separated by 1 week.

Primary outcomes

  1. 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

Secondary outcomes

  1. To define the pharmacokinetics of GIPET enhanced oral Acyline

    Time frame: 28-days

  2. Assess any potential side effects of GIPET enhanced oral Acyline

    Time frame: 28-days

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Merrion Pharmaceuticals, LLC

Registry information

Official study title

Oral Administration of the GnRH Antagonist Acyline in Normal Men

Acronym: ACY-6

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
May 9, 2007
Registry last updated
Dec 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.