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

NCT00769041 | Completed Phase 1

• 1 other identifier: TA-140
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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.

  24 Hours

Study Arms (4)

placebo

PLACEBO COMPARATOR

Drug: sugar pill

moxifloxacin

ACTIVE COMPARATOR

Drug: moxifloxacin

avanafil therapeutic

EXPERIMENTAL

avanafil 100mg - therapeutic dose

Drug: avanafil

avanafil supratherapeutic

EXPERIMENTAL

avanafil 800mg - supratherapeutic dose

Drug: avanafil

Interventions

moxifloxacin DRUG

400mg

moxifloxacin

avanafil DRUG

100mg single dose

avanafil therapeutic

sugar pill DRUG

single dose

placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male;
• 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.

You may not qualify if:

• 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 (Viagra®), vardenafil (Levitra®), tadalafil (Cialis®) 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.
• Subjects who have a sustained supine SBP \>140 mmHg or \<100 mm Hg or a DBP \>95 mmHg at Screening or baseline.
• Subjects who have a resting HR of \<45 bpm or \>100 bpm.
• Subjects who have an abnormal Screening ECG indicating a second- or third-degree atrioventricular (AV) block, or 1 or more of the following: QRS interval \>110 msec, QTc interval \>450 msec, PR interval \>240 msec, or any rhythm other than sinus rhythm, which is interpreted by the Investigator to be clinically significant.
• Subjects who use or have used tobacco-containing products within the 6 months prior to Period 1 Check-in and throughout the study.
• Subjects who have consumed alcohol-, caffeine-, or xanthine-containing products within 72 hours prior to Period 1 Check-in and throughout the study.

Sponsors & Collaborators

• VIVUS LLC: lead
• Covance: collaborator

Study Sites (1)

Covance Phase 1 Clinical Unit

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Moxifloxacin; avanafil; Sugars

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Carbohydrates

Study Officials

• Chuck Bowden, M.D.

  VIVUS LLC

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 6, 2008
• First Posted: October 8, 2008
• Study Start: October 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: January 7, 2011

Record last verified: 2011-01

Locations

US (1)