A Study To Determine Any Effect Of Tafamidis On Electrocardiographic Intervals, Specifically The Rate Corrected QT Interval (QTc)
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 3/30/2013 |
| Start Date: | January 2013 |
| End Date: | May 2013 |
| Contact: | Pfizer CT.gov Call Center |
| Phone: | 1-800-718-1021 |
A Randomized, Placebo- And Positive-Controlled Cross-Over Study To Evaluate The Effect Of Tafamidis On The QTC Interval In Healthy Volunteers
The purpose of this study is to investigate the effects of tafamidis on the intervals of the
electrocardiogram, specifically the rate corrected QT interval (QTc) in healthy volunteers.
Inclusion Criteria:
- Healthy, nonsmoking, male and/or female subjects of non-childbearing potential.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
- Total body weight >50 kg (110 lbs).
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease.
- An ALT or AST measurement >2 times the ULN.
- 12-lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec at Screening.
- Subjects at increased risk if dosed with moxifloxacin, according to the product label
for moxifloxacin.
- History of risk factors of QT prolongation or torsades de pointes, congenital
deafness and family history of sudden death.
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