ACY-6 Oral Administration of Acyline

Sponsor
University of Washington (Other)
Overall Status
Completed
CT.gov ID
NCT00471185
Collaborator
Merrion Pharmaceuticals, LLC (Industry)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Oral Administration of the GnRH Antagonist Acyline in Normal Men
Study Start Date :
Jun 1, 2007
Actual Primary Completion Date :
Aug 1, 2007
Actual Study Completion Date :
Aug 1, 2007

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  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 [28-days]

Secondary Outcome Measures

  1. To define the pharmacokinetics of GIPET enhanced oral Acyline [28-days]

  2. Assess any potential side effects of GIPET enhanced oral Acyline [28-days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00471185
Other Study ID Numbers:
  • 31511-W
  • 07-4947-W 02
First Posted:
May 9, 2007
Last Update Posted:
Dec 3, 2010
Last Verified:
Dec 1, 2010
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 3, 2010