A Blinded, Randomized Crossover Trial to Define the ECG Effects of TA-1790 (Avanafil) Using a Single Clinical and a Supratherapeutic Dose Compared to Placebo and Moxifloxacin in Healthy Men: A Thorough ECG Trial

VIVUS LLC1 site in 1 country57 target enrollmentOctober 2008

ConditionsErectile Dysfunction

Interventionssugar pill moxifloxacin avanafil

Drugsmoxifloxacin avanafil sugar pill

Overview

Phase: Phase 1
Intervention: sugar pill
Conditions: Erectile Dysfunction
Sponsor: VIVUS LLC
Enrollment: 57
Locations: 1
Primary Endpoint: Time-matched change from baseline in QTcI that provides optimization of QT correction of heart rate as compared to fixed exponent approaches such as QTcB or QTcF.
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 2008

End Date

January 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

VIVUS LLC

Eligibility Criteria

Inclusion Criteria

•Between 18 and 45 years of age, inclusive;
•Have a BMI ranging between 19 and 28 kg/m2, inclusive;
•Have no clinically significant abnormal findings on the physical examination, ECG, blood pressure, HR, medical history, or clinical laboratory results during Screening;
•Be willing and able to comply with all trial requirements; and
•Have given written informed consent.

Exclusion Criteria

•Subjects who have participated in another clinical trial of an within the last 30 days or are currently participating in another trial of an investigational drug.
•Subjects who have participated in a previous clinical trial with avanafil.
•Subjects who have a known allergy or hypersensitivity to avanafil, sildenafil (ViagraÂ®), vardenafil (LevitraÂ®), tadalafil (CialisÂ®) or any of the components of these drug products; moxifloxacin or its components; or to any quinolone antibiotic.
•Subjects who have experienced dose-limiting adverse effects during therapy with a PDE5
•Subjects who have any condition possibly affecting drug absorption
•Subjects who have evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine,pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease. Exceptions to these criteria (eg, stable, mild joint disease) may be made following discussions with the Medical Monitor.
•Subjects with a medical history of or who have a positive serology test for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg), or hepatitis C virus (HCV).
•Subjects who have a history of drug or alcohol abuse or dependence within 18 months prior to Screening.
•Subjects who have donated blood or blood components within the 4 weeks prior to Period 1 Check-in.
•Subjects with laboratory values outside of the normal range for the local laboratory.

Arms & Interventions

placebo

Intervention: sugar pill

moxifloxacin

Intervention: moxifloxacin

avanafil therapeutic

avanafil 100mg - therapeutic dose

Intervention: avanafil

avanafil supratherapeutic

avanafil 800mg - supratherapeutic dose

Intervention: avanafil

Outcomes

Primary Outcomes

Time-matched change from baseline in QTcI that provides optimization of QT correction of heart rate as compared to fixed exponent approaches such as QTcB or QTcF.

Time Frame: 24 Hours