A Phase I Crossover Study of the Hemodynamic Interactions of Avanafil & Alcohol in Healthy Male Subjects.
This study has been completed.
Sponsor:
VIVUS, Inc.
Information provided by:
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT01054859
First received: January 20, 2010
Last updated: January 5, 2011
Last verified: January 2011
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Purpose
The purpose of this study is primarily to evaluate whether taking avanafil with alcohol causes the blood pressure to fall.
| Condition | Intervention | Phase |
|---|---|---|
|
Erectile Dysfunction |
Drug: avanafil Other: alcohol |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by VIVUS, Inc.:
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. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
| Enrollment: | 15 |
| Study Start Date: | January 2010 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment A
0.5 g/Kg alcohol plus 200 mg avanafil tablet
|
Drug: avanafil
200 mg avanafil tablet QD plus 0.5 g/kg alcohol
|
|
Active Comparator: Treatment B
0.5 g/kg alcohol
|
Other: alcohol
0.5 g/kg alcohol
|
|
Active Comparator: Treatment C
200 mg avanafil tablet
|
Drug: avanafil
200 mg avanafil tablet QD
|
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.
Eligibility| Ages Eligible for Study: | 21 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Wesley Day, VP Clinical Development, Vivus, Inc. |
| ClinicalTrials.gov Identifier: | NCT01054859 History of Changes |
| Other Study ID Numbers: | TA-015 |
| Study First Received: | January 20, 2010 |
| Last Updated: | January 5, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Erectile Dysfunction Sexual Dysfunction, Physiological Genital Diseases, Male Sexual Dysfunctions, Psychological Sexual and Gender Disorders Mental Disorders Ethanol |
Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013