ACY-7 Oral Administration of Acyline

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Washington
• Collaborator: Merrion Pharmaceuticals, LLC
• Treatments: Acyline

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.