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| Sponsor: | VIVUS, Inc. |
|---|---|
| Collaborator: |
Covance |
| Information provided by: | VIVUS, Inc. |
| ClinicalTrials.gov Identifier: | NCT00769041 |
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 I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety Study |
| 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 |
| Estimated Enrollment: | 57 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | April 2009 |
| Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| placebo: Placebo Comparator |
Drug: sugar pill
single dose
|
| moxifloxacin: Active Comparator |
Drug: moxifloxacin
400mg
|
|
avanafil therapeutic: Experimental
avanafil 100mg - therapeutic dose
|
Drug: avanafil
100mg single dose
|
|
avanafil supratherapeutic: Experimental
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | VIvus, Inc. ( Wesley Day, VP Clinical ) |
| Study ID Numbers: | TA-140 |
| Study First Received: | October 6, 2008 |
| Last Updated: | March 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00769041 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Sexual Dysfunctions, Psychological Anti-Infective Agents Sexual Dysfunction, Physiological Moxifloxacin Mental Disorders |
Therapeutic Uses Genital Diseases, Male Sexual and Gender Disorders Erectile Dysfunction Pharmacologic Actions |