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

NCT ID: NCT01054859

Last Updated: 2011-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment A

0.5 g/Kg alcohol plus 200 mg avanafil tablet

Group Type: EXPERIMENTAL

avanafil

Intervention Type: DRUG

200 mg avanafil tablet QD plus 0.5 g/kg alcohol

Treatment B

0.5 g/kg alcohol

Group Type: ACTIVE_COMPARATOR

alcohol

Intervention Type: OTHER

0.5 g/kg alcohol

Treatment C

200 mg avanafil tablet

Group Type: ACTIVE_COMPARATOR

avanafil

Intervention Type: DRUG

200 mg avanafil tablet QD

Interventions

avanafil

200 mg avanafil tablet QD plus 0.5 g/kg alcohol

Intervention Type: DRUG

alcohol

0.5 g/kg alcohol

Intervention Type: OTHER

avanafil

200 mg avanafil tablet QD

Intervention Type: DRUG

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

• 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;

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

VIVUS LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Vivus, Inc.

Principal Investigators

Shiyin Yee, PhD

Role: STUDY_DIRECTOR

VIVUS LLC

Other Identifiers

TA-015

Identifier Type: -

Identifier Source: org_study_id