Study the Effect of Avanafil on the Pharmacodynamics and Pharmacokinetics of Warfarin in Healthy Male Subjects

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study is designed to look into the effect of avanafil on blood levels of warfarin and to investigate its effect on prothrombin time/international normalized ratio (INR) in healthy men.

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

Details

• Lead Sponsor: VIVUS, Inc.
• Treatments: Warfarin

Criteria

Inclusion Criteria:

• adult male subjects,

• 21 to 45 years of age,

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

Exclusion Criteria:

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

• any clinically significant laboratory abnormalities as judged by the investigator;

• systolic blood pressure < 90 or >120 mmHg;

• diastolic blood pressure < 50 or > 90 mmHg;

• allergy to or previous adverse events with PDE5 inhibitors, warfarin or their constituents;

• 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 and drug test;

• positive serum cotinine test;

• positive serology for HIV, HCV, HBsAg.