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

Pfizer logo

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

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

Trial contacts and locations

3

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems