ACY-7 Oral Administration of Acyline - Full Text View

Sponsors and Collaborators:	University of Washington Merrion Pharmaceuticals, LLC
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00603187

Purpose

We propose oral dosing of 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 I Phase II

Drug Information available for: Gonadorelin Gonadorelin hydrochloride LH-RH Acyline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Pharmacokinetics Study
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:

To evaluate the suppressive effects of 7 days of 20 mg of GIPET-enhanced oral Acyline on pituitary gonadotropin and testosterone secretion in normal men [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess any potential side effects of 7 days of 20 mg of GIPET enhanced oral Acyline [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
To define the steady-state pharmacokinetics of once-daily dosing of 20 mg of GIPET enhanced oral Acyline [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated 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)

Arms	Assigned Interventions
1: Experimental 20 mg dose of GIPET enhanced oral acyline for 7 days	Drug: Acyline 20 mg 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 normal 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.

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

University of Washington This link exits the ClinicalTrials.gov site

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 Aug 29; [Epub ahead of print]

Responsible Party:	University of Washington ( John K Amory, MD, MPH )
Study ID Numbers:	07-7973-W
Study First Received:	January 15, 2008
Last Updated:	September 18, 2008
ClinicalTrials.gov Identifier:	NCT00603187
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Washington:

Male Contraception
Acyline

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 14, 2009