ACY-6 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:	NCT00471185

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 I

MedlinePlus related topics: Birth Control

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics Study
Official Title:	Oral Administration of the GnRH Antagonist Acyline in Normal Men

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
A: Experimental 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

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

Related Info 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:	07-4947-W/B
Study First Received:	May 7, 2007
Last Updated:	September 18, 2008
ClinicalTrials.gov Identifier:	NCT00471185
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Washington:

Male Contraception
Acyline

ClinicalTrials.gov processed this record on January 14, 2009