ACY-6 Oral Administration of Acyline (ACY-6)

December 2, 2010 updated by: University of Washington

Oral Administration of the GnRH Antagonist Acyline in Normal Men

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 28-days
28-days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Merrion Pharmaceuticals, LLC

Investigators

  • Principal Investigator: John K Amory, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

May 7, 2007

First Submitted That Met QC Criteria

May 8, 2007

First Posted (Estimate)

May 9, 2007

Study Record Updates

Last Update Posted (Estimate)

December 3, 2010

Last Update Submitted That Met QC Criteria

December 2, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31511-W
  • 07-4947-W 02 (Other Identifier: UW Human Subjects Division)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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