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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01054859

Enrollment

Registered

2010-01-22

Start date

2010-01-31

Completion date

2010-01-31

Last updated

2011-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

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.

Interventions

DRUGavanafil

200 mg avanafil tablet QD plus 0.5 g/kg alcohol

OTHERalcohol

0.5 g/kg alcohol

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

21 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
For supine systolic (SBP) and diastolic (DBP) blood pressure, the area under effect-time curve (AUEC0- t), expressed as change from baseline and the maximum decrease in blood pressure. For supine pulse rate, maximum increase in pulse rate.	1 day

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026