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

This study has been completed.
Sponsor:
Information provided by:
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT01054859
First received: January 20, 2010
Last updated: January 5, 2011
Last verified: January 2011
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01054859

Sponsors and Collaborators
VIVUS, Inc.
Investigators
Study Director: Shiyin Yee, PhD VIVUS, Inc.
  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
Genital Diseases, Male
Mental Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Ethanol
Anti-Infective Agents
Anti-Infective Agents, Local
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014