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

Phase 1

Completed

• Conditions: TTR Cardiomyopathy
• Interventions: Drug: Period 1; Drug: Period 2; Drug: Period 3

• Registration Number: NCT01775761
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-15
• Study First Submitted QC: 2013-01-22
• Study First Posted: 2013-01-25
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-20
• Last Update Posted: 2013-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Period 1: 960 mg tafamidis (Vyndaqel)	Period 1	-
Period 2: 400 mg moxifloxacin	Period 2	400 mg moxifloxacin
Period 3: Placebo	Period 3	-

Primary Outcome Measures

Name	Time	Method
QTc interval using Fridericia's correction method (QTcF) of tafamidis and placebo (baseline-adjusted) at each post-dose time	SCRN, -1, -0.5, 0, 1, 1.5, 2, 3, 4, 6, 12, 24 hrs

Secondary Outcome Measures

Name	Time	Method
QTcF of moxifloxacin and placebo at historical moxifloxacin median Tmax of 3 hours.	Scrn, -1, -0.5, 0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs
Tmax	0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs
Cmax	0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs
AUC0-24	0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore