A Pharmacokinetic Study of Avanfil in Healthy Young Male Subjects

Exclusion Criteria

• •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