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

Pfizer

Status and phase: Completed; Phase 1

Conditions: TTR Cardiomyopathy

Treatments: Drug: Period 3; Drug: Period 2; Drug: Period 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT01775761

B3461031

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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42 participants in 3 patient groups

Period 1: 960 mg tafamidis (Vyndaqel)

Experimental group

Treatment:

Drug: Period 1

Period 2: 400 mg moxifloxacin

Experimental group

Description:

400 mg moxifloxacin

Treatment:

Drug: Period 2

Period 3: Placebo

Experimental group

Treatment:

Drug: Period 3