A Study To Determine Any Effect Of Tafamidis On Electrocardiographic Intervals, Specifically The Rate Corrected QT Interval (QTc)

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

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.