Back to resultsA Phase I Crossover Study of the Hemodynamic Interactions of Avanafil & Alcohol in Healthy Male Subjects.
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
avanafil
alcohol
avanafil
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Treatment A
Treatment B
Treatment C
Arm Description
0.5 g/Kg alcohol plus 200 mg avanafil tablet
0.5 g/kg alcohol
200 mg avanafil tablet
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01054859
Brief Title
A Phase I Crossover Study of the Hemodynamic Interactions of Avanafil & Alcohol in Healthy Male Subjects.
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 Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
VIVUS LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment A
Arm Type
Experimental
Arm Description
0.5 g/Kg alcohol plus 200 mg avanafil tablet
Arm Title
Treatment B
Arm Type
Active Comparator
Arm Description
0.5 g/kg alcohol
Arm Title
Treatment C
Arm Type
Active Comparator
Arm Description
200 mg avanafil tablet
Intervention Type
Drug
Intervention Name(s)
avanafil
Intervention Description
200 mg avanafil tablet QD plus 0.5 g/kg alcohol
Intervention Type
Other
Intervention Name(s)
alcohol
Intervention Description
0.5 g/kg alcohol
Intervention Type
Drug
Intervention Name(s)
avanafil
Intervention Description
200 mg avanafil tablet QD
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiyin Yee, PhD
Organizational Affiliation
VIVUS LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Phase I Crossover Study of the Hemodynamic Interactions of Avanafil & Alcohol in Healthy Male Subjects.
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