ACY-6 Oral Administration of Acyline

This study has been completed.
Sponsor:
Collaborator:
Merrion Pharmaceuticals, LLC
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00471185
First received: May 7, 2007
Last updated: December 2, 2010
Last verified: December 2010
  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

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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 Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471185

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Merrion Pharmaceuticals, LLC
Investigators
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 August 19, 2014