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ACY-7 Oral Administration of Acyline

This study has been completed.
Sponsor:
Collaborator:
Merrion Pharmaceuticals, LLC
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00603187
First received: January 15, 2008
Last updated: May 10, 2011
Last verified: May 2011
History of Changes
  Purpose

We propose oral dosing of gastrointestinal permeation enhancement technology [GIPET] enhanced oral acyline at 20 mg everyday for one week to determine the steady-state (multiple-dose) pharmacokinetics of oral acyline in four normal, healthy young men.


Condition Intervention Phase
Healthy
 Drug: Acyline
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oral Administration of the GnRH Antagonist Acyline in Normal Men Part II: Multiple-dose Pharmacokinetics (Acyline-7/MER 104-02)

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Testosterone Blood Serum Concentration [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Blood for measurement of serum testosterone was obtained prior to the 1st, 5th and 6th dose of GIPET™-enhanced oral acyline and 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 60 hours after the 7th dose.


Secondary Outcome Measures:
  • FSH Blood Serum Concentration [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Blood for measurement of serum follicle stimulating hormone concentrations was obtained prior to the 1st, 5th and 6th dose of GIPET™-enhanced oral acyline and 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 60 hours after the 7th dose.

  • LH Blood Serum Concentration [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Blood for measurement of serum leutenizing hormone concentrations was obtained prior to the 1st, 5th and 6th dose of GIPET™-enhanced oral acyline and 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 60 hours after the 7th dose.


Enrollment: 4
Study Start Date: January 2008
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Acyline
    20 mg GIPET enhanced oral dose, daily for 7-days
Detailed Description:

The purpose of this study is to test how the body responds to a new oral form of acyline given for seven days and to also look at the safety of oral acyline.

Acyline temporarily blocks the production of the hormone testosterone in healthy men. It has been tested in over 100 men in an injection form. This study will be testing acyline in a pill form for seven days.

This study may help develop an oral form of 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 will evaluate a single dose of oral acyline given once a day for seven days and subsequent effects on Testosterone, FSH and LH blood serum concentrations.

  Eligibility

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

Inclusion Criteria:

  • Healthy male
  • 18-50 years of age
  • Non-smoker
  • Not taking any medications other than the study drug for the duration of the study.
  • Must be willing to use an accepted method of contraception during the study.

Exclusion Criteria:

  • BMI > 35
  • Abnormal evaluation on screening exam and labs
  • Known history of alcohol abuse, illicit drugs or steroids and/or use of more that 3 alcoholic beverages/day
  • History of current testosterone use or infertility
  • History of testicular disease or severe testicular trauma
  • History of major psychiatric disorder or sleep apnea
  • History of bleeding disorder or need for anticoagulation
  • Current smoker or utilizing nicotine patches or gum
  • Participation in a hormonal drug study within past month.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603187

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, MD, MPH University of Washington
  More Information

Additional Information:
University of Washington  This link exits the ClinicalTrials.gov site
University of Washington  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: John K Amory, MD, MPH, University of Washington
ClinicalTrials.gov Identifier: NCT00603187     History of Changes
Other Study ID Numbers: 32716-W, 07-7973-W
Study First Received: January 15, 2008
Results First Received: January 10, 2011
Last Updated: May 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Washington:
Male Contraception
Acyline

ClinicalTrials.gov processed this record on May 16, 2013