NCT01054859

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

A PHASE I, A SINGLE-CENTRE, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, THREE-PERIOD, THREE-WAY CROSSOVER STUDY OF THE HEMODYNAMIC INTERACTIONS OF AVANAFIL AND ALCOHOL IN HEALTHY MALE SUBJECTS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: VIVUS LLC · Industry
• Sex: Male
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is primarily to evaluate whether taking avanafil with alcohol causes the blood pressure to fall.

Detailed description

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 kilogram of body weight). * Treatment C: a single oral dose of one 200 mg avanafil tablet plus an oral dose of placebo drink mixed with fruit juice. For each treatment period, Dinamap (or DataScope) automatic measurements of supine blood pressure and pulse rate will be taken pre-dose and every 15 minutes for 4 hours post-dose. Alcohol levels using a breathalyzer will be measured at pre-dose and up to 8 hours post dose during all 3 treatments by designated unblinded personnel. Subjects should be supine for at least 5-10 minutes before the blood pressure and heart rate measurement.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	avanafil	200 mg avanafil tablet QD plus 0.5 g/kg alcohol
OTHER	alcohol	0.5 g/kg alcohol
DRUG	avanafil	200 mg avanafil tablet QD

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2010-01-22
• Last updated: 2011-01-07