A Pharmacokinetic Study of Avanfil in Healthy Young Male Subjects

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purposes of this study are to:

• Determine the effect of the study drug on sperm and semen of healthy young male subjects.

• Determine the effect of age on the amount of study drug in the blood of healthy subjects

• Learn about the safety of the study drug.

• Learn how subjects tolerate the study drug.

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

Details

• Lead Sponsor: VIVUS, Inc.

Criteria

Inclusion Criteria:

• Cohort A: Adult male subjects of 18 to 45 years of age inclusive Cohort B: Adult male subjects at least 65 years of age

• All subjects must be medically healthy with no clinically significant screening results.

• Male subjects should be willing to use a condom and spermicide during sexual activity for 90 days after last dosing of Avanafil and be willing to not donate sperm for 90 days after dosing.

Exclusion Criteria:

Major exclusion criteria for all subjects include:

• History or clinical evidence of clinically relevant cardiovascular (including thromboembolic disorders), hepatic, renal, hematologic, endocrine, pulmonary, gastrointestinal, psychiatric or neurological impairment

• Any clinically significant laboratory abnormalities as judged by the investigator

• Systolic blood pressure < 90 or >150 mmHg

• Diastolic blood pressure < 50 or > 95 mmHg

• Allergy to or previous adverse events with PDE5 inhibitors

• Use of prescription or over-the-counter drugs that are known to interfere with metabolism by the cytochrome P450 3A4 enzyme within 30 days of screening

• Use of any investigational drug within 30 days of screening

• Use of any prescription or over-the-counter drugs or herbal remedies within 14 days of screening

• History of alcohol or drug abuse within 18 months, history of smoking within 6 months

• Positive urine alcohol test

• Positive urine drug screen

• Positive urine cotinine test, positive serology for HIV, HCV, HBsAg

• Young males who have undergone vasectomy cannot participate in this-study

• Additional exclusion criteria are listed in Section 4.2.