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ACY-7 Oral Administration of Acyline (ACY-7)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00603187
First Posted: January 28, 2008
Last Update Posted: June 9, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merrion Pharmaceuticals, LLC
Information provided by:
University of Washington
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications:
Herbst KL, Anawalt BD, Amory JK, Bremner WJ. Acyline: the first study in humans of a potent, new gonadotropin-releasing hormone antagonist. J Clin Endocrinol Metab. 2002 Jul;87(7):3215-20.
Herbst KL, Coviello AD, Page S, Amory JK, Anawalt BD, Bremner WJ. A single dose of the potent gonadotropin-releasing hormone antagonist acyline suppresses gonadotropins and testosterone for 2 weeks in healthy young men. J Clin Endocrinol Metab. 2004 Dec;89(12):5959-65.
Matthiesson KL, Amory JK, Berger R, Ugoni A, McLachlan RI, Bremner WJ. Novel male hormonal contraceptive combinations: the hormonal and spermatogenic effects of testosterone and levonorgestrel combined with a 5alpha-reductase inhibitor or gonadotropin-releasing hormone antagonist. J Clin Endocrinol Metab. 2005 Jan;90(1):91-7. Epub 2004 Oct 27.
Amory JK, Bremner WJ. Oral testosterone in oil plus dutasteride in men: a pharmacokinetic study. J Clin Endocrinol Metab. 2005 May;90(5):2610-7. Epub 2005 Feb 15.
Amory JK, Page ST, Bremner WJ. Oral testosterone in oil: pharmacokinetic effects of 5alpha reduction by finasteride or dutasteride and food intake in men. J Androl. 2006 Jan-Feb;27(1):72-8.
Page ST, Lin DW, Mostaghel EA, Hess DL, True LD, Amory JK, Nelson PS, Matsumoto AM, Bremner WJ. Persistent intraprostatic androgen concentrations after medical castration in healthy men. J Clin Endocrinol Metab. 2006 Oct;91(10):3850-6. Epub 2006 Aug 1.
Page ST, Amory JK, Anawalt BD, Irwig MS, Brockenbrough AT, Matsumoto AM, Bremner WJ. Testosterone gel combined with depomedroxyprogesterone acetate is an effective male hormonal contraceptive regimen and is not enhanced by the addition of a GnRH antagonist. J Clin Endocrinol Metab. 2006 Nov;91(11):4374-80. Epub 2006 Aug 29.

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 ( Other Identifier: UW Human Subjects Division )
First Submitted: January 15, 2008
First Posted: January 28, 2008
Results First Submitted: January 10, 2011
Results First Posted: June 9, 2011
Last Update Posted: June 9, 2011
Last Verified: May 2011

Keywords provided by University of Washington:
Male Contraception
Acyline


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