ACY-7 Oral Administration of Acyline

Phase 1

Completed

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.

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
Testosterone Blood Serum Concentration	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

Name	Time	Method
FSH Blood Serum Concentration	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	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.