Assess the Effect of Food on Avanafil Pharmacokinetic (PK), to Compare 2 Oral Formulations of Avanafil,and Investigate Dose Proportionality in Healthy Male Subjects

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

Summary

This study will assess the effect of food on the pharmacokinetics of avanafil (Formulation II); determine the relative bioavailability of two avanafil tablet formulations (Formulation I versus Formulation II) and will investigate the dose-proportionality of Formulation II avanafil tablet.

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

Details

• Lead Sponsor: VIVUS, Inc.

Criteria

Inclusion Criteria:

• adult male subjects,

• 18 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 >150 mmHg;

• diastolic blood pressure < 50 or > 95 mmHg;

• history of retinitis pigmentosa or nonarteritic anterior ischemic optic neuropathy; allergy to or previous adverse events with PDE5 inhibitors 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 prior to Day 1 in Period 1;

• use of any investigational drug within 30 days or six half-lives, whichever is longer, prior to Day 1 in Period 1;

• use of any prescription or over-the-counter drugs or herbal remedies within 14 days prior to Day 1 in Period 1;

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

• positive urine alcohol test;

• positive cotinine test, positive urine drug screen;

• positive serology for HIV, HCV antibody, HBsAg.