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

This study has been completed.
Sponsor:
Collaborator:
Covance
Information provided by:
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT00769041
First received: October 6, 2008
Last updated: January 5, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Erectile Dysfunction
Drug: moxifloxacin
Drug: avanafil
Drug: sugar pill
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by VIVUS, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 57
Study Start Date: October 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Drug: sugar pill
single dose
Active Comparator: moxifloxacin Drug: moxifloxacin
400mg
Experimental: avanafil therapeutic
avanafil 100mg - therapeutic dose
Drug: avanafil
100mg single dose
Experimental: avanafil supratherapeutic
avanafil 800mg - supratherapeutic dose
Drug: avanafil
800mg single dose

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. Subjects who have participated in a previous clinical trial with avanafil.
  3. 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.
  4. Subjects who have experienced dose-limiting adverse effects during therapy with a PDE5
  5. Subjects who have any condition possibly affecting drug absorption
  6. 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.
  7. 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).
  8. Subjects who have a history of drug or alcohol abuse or dependence within 18 months prior to Screening.
  9. Subjects who have donated blood or blood components within the 4 weeks prior to Period 1 Check-in.
  10. Subjects with laboratory values outside of the normal range for the local laboratory.
  11. Subjects who have a sustained supine SBP >140 mmHg or <100 mm Hg or a DBP >95 mmHg at Screening or baseline.
  12. Subjects who have a resting HR of <45 bpm or >100 bpm.
  13. 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.
  14. Subjects who use or have used tobacco-containing products within the 6 months prior to Period 1 Check-in and throughout the study.
  15. Subjects who have consumed alcohol-, caffeine-, or xanthine-containing products within 72 hours prior to Period 1 Check-in and throughout the study.
  16. Subjects who test positive for drug(s) of abuse, alcohol, or cotinine at Screening or Check-in for any period.
  17. Subjects who have concomitant medication usage of any nitrate, trazadone, ketoconozole, erythromycin, cimetidine, androgen replacement therapy and/or use of other prescription or over-the-counter drugs that are known to interfere with metabolism by CYP3A4.
  18. Subjects who have used any drug that may prolong the QT/QTc interval within 30 days.
  19. Subjects who have used a prescription drug or over-the-counter or herbal medication within 14 days
  20. Subjects who are involved in the planning and/or conduct of the study.
  21. Subjects who, for any reason, are deemed by the Investigator to be inappropriate for this study, including subjects who are unable to communicate or to cooperate with the Investigator.
  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: NCT00769041

Locations
United States, Wisconsin
Covance Phase 1 Clinical Unit
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
VIVUS, Inc.
Covance
Investigators
Study Director: Chuck Bowden, M.D. VIVUS, Inc.
  More Information

No publications provided

Responsible Party: Wesley Day, VP Clinical, VIvus, Inc.
ClinicalTrials.gov Identifier: NCT00769041     History of Changes
Other Study ID Numbers: TA-140
Study First Received: October 6, 2008
Last Updated: January 5, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 31, 2014