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

January 15, 2008
May 10, 2011
January 2008
February 2008   (final data collection date for primary outcome measure)
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.
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 ]
Complete list of historical versions of study NCT00603187 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 ]
Not Provided
Not Provided
 
ACY-7 Oral Administration of Acyline
Oral Administration of the GnRH Antagonist Acyline in Normal Men Part II: Multiple-dose Pharmacokinetics (Acyline-7/MER 104-02)

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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
Drug: Acyline
20 mg GIPET enhanced oral dose, daily for 7-days
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4
February 2008
February 2008   (final data collection date for primary outcome measure)

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.
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00603187
32716-W, 07-7973-W
No
John K Amory, MD, MPH, University of Washington
University of Washington
Merrion Pharmaceuticals, LLC
Principal Investigator: John K Amory, MD, MPH University of Washington
University of Washington
May 2011

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