NCT01054859

Brief Summary

The purpose of this study is primarily to evaluate whether taking avanafil with alcohol causes the blood pressure to fall.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2010

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2010

Completed
Last Updated

January 7, 2011

Status Verified

January 1, 2011

Enrollment Period

Same day

First QC Date

January 20, 2010

Last Update Submit

January 5, 2011

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Treatment A

EXPERIMENTAL

0.5 g/Kg alcohol plus 200 mg avanafil tablet

Drug: avanafil

Treatment B

ACTIVE COMPARATOR

0.5 g/kg alcohol

Other: alcohol

Treatment C

ACTIVE COMPARATOR

200 mg avanafil tablet

Drug: avanafil

Interventions

avanafilDRUG

200 mg avanafil tablet QD plus 0.5 g/kg alcohol

Treatment A
alcoholOTHER

0.5 g/kg alcohol

Treatment B

Eligibility Criteria

Age21 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult male subjects,
  • either 21 to 45 years of age,
  • must be medically healthy with no clinically significant screening results.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

avanafilEthanol

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Shiyin Yee, PhD

    VIVUS LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 20, 2010

First Posted

January 22, 2010

Study Start

January 1, 2010

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

January 7, 2011

Record last verified: 2011-01