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A Thorough EKG Safety Study of TA-1790 (Avanafil)

NCT00769041 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2011-01-07

No results posted yet for this study

Summary

This study is to assess whether treatment with a therapeutic (100 mg) or supratherapeutic (800 mg) dose of avanafil has the potential to cause QT/QTc prolongation in healthy volunteers.

Conditions

Interventions

DRUG

moxifloxacin

400mg

DRUG

avanafil

100mg single dose

DRUG

avanafil

800mg single dose

DRUG

sugar pill

single dose

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • VIVUS LLC

    lead INDUSTRY

Principal Investigators

  • Chuck Bowden, M.D. · VIVUS LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00769041 on ClinicalTrials.gov