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

Tracking Information

First Received Date ^ICMJE

January 15, 2008

Last Updated Date

May 10, 2011

Start Date ^ICMJE

January 2008

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00603187 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

ACY-7 Oral Administration of Acyline

Official Title ^ICMJE

Oral Administration of the GnRH Antagonist Acyline in Normal Men Part II: Multiple-dose Pharmacokinetics (Acyline-7/MER 104-02)

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: Acyline

20 mg GIPET enhanced oral dose, daily for 7-days

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2008

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00603187

Other Study ID Numbers ^ICMJE

32716-W, 07-7973-W

Has Data Monitoring Committee

Responsible Party

John K Amory, MD, MPH, University of Washington

Study Sponsor ^ICMJE

University of Washington

Collaborators ^ICMJE

Merrion Pharmaceuticals, LLC

Investigators ^ICMJE

Principal Investigator:

John K Amory, MD, MPH

University of Washington

Information Provided By

University of Washington

Verification Date

May 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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