A Phase I Crossover Study of the Hemodynamic Interactions of Avanafil & Alcohol in Healthy Male Subjects.
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|ClinicalTrials.gov Identifier: NCT01054859|
Recruitment Status : Completed
First Posted : January 22, 2010
Last Update Posted : January 7, 2011
|Condition or disease||Intervention/treatment||Phase|
|Erectile Dysfunction||Drug: avanafil Other: alcohol||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
Experimental: Treatment A
0.5 g/Kg alcohol plus 200 mg avanafil tablet
200 mg avanafil tablet QD plus 0.5 g/kg alcohol
Active Comparator: Treatment B
0.5 g/kg alcohol
0.5 g/kg alcohol
Active Comparator: Treatment C
200 mg avanafil tablet
200 mg avanafil tablet QD
- 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. [ Time Frame: 1 day ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01054859
|Study Director:||Shiyin Yee, PhD||VIVUS, Inc.|