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

Completed · Phase 1 · Has a placebo group

Conditions studied: TTR Cardiomyopathy

In brief

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.

Key facts

Study ID

NCT01775761

Run by

Pfizer

People needed

42

Starts

2013-01-01

Expected to finish

2013-04-01

Last updated by the study team

2013-05-21

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — New Haven, Connecticut, United States
• Pfizer Investigational Site — Brussels, Belgium
• Pfizer Investigational Site — Singapore, Singapore, Singapore

Full record on ClinicalTrials.gov

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