A Phase I Crossover Study of the Hemodynamic Interactions of Avanafil & Alcohol in Healthy Male Subjects.

Launched by VIVUS LLC · Jan 21, 2010

Keywords

ClinConnect Summary

The trial is a single-centre double-blind, randomized, placebo-controlled, three-period, three-way crossover study, in which each subject will be randomized to receive each of the following three treatments with a washout period of at least 5 days between treatments:

* Treatment A: a single oral dose of one 200 mg avanafil tablet plus an oral dose of alcohol drink mixed with fruit juice (0.5 g of absolute ethanol per kilogram of body weight).
* Treatment B: a single oral dose of one placebo tablet plus an oral dose of alcohol drink mixed with fruit juice (0.5 g of absolute ethanol per kilo...

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Adult male subjects,
• • either 21 to 45 years of age,
• • must be medically healthy with no clinically significant screening results.
• Exclusion Criteria:
• • Major exclusion criteria include: 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;
• • allergy to or previous adverse events with PDE5 inhibitors, alcohol 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 Day 1 dosing (Period 1);
• • use of any investigational drug within 30 days of Day 1 dosing (Period 1);
• • use of any prescription or over-the-counter drugs or herbal remedies within 14 days of Day 1 dosing (Period 1);
• • history of alcohol or drug abuse within 18 months, history of smoking within 6 months; positive breath alcohol, positive cotinine test or positive urine drug screen at screening or on Day -1;
• • positive serology for HIV, HCV, HBsAg. Additional exclusion criteria are listed in Section 4.2.