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

Primary Purpose

TTR Cardiomyopathy

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Period 1

Period 2

Period 3

About this trial

This is an interventional basic science trial for TTR Cardiomyopathy focused on measuring Thorough QTc evaluation of tafamidis compared to the effects of moxifloxacin and placebo in healthy volunteers.

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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.

Sites / Locations

Pfizer Investigational Site
Pfizer Investigational Site
Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Period 1: 960 mg tafamidis (Vyndaqel)

Period 2: 400 mg moxifloxacin

Period 3: Placebo

Arm Description

400 mg moxifloxacin

Outcomes

Primary Outcome Measures

QTc interval using Fridericia's correction method (QTcF) of tafamidis and placebo (baseline-adjusted) at each post-dose time

Secondary Outcome Measures

QTcF of moxifloxacin and placebo at historical moxifloxacin median Tmax of 3 hours.

Tmax

Cmax

AUC0-24

Full Information

NCT ID

NCT01775761

First Posted

January 15, 2013

Last Updated

May 20, 2013

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01775761

Brief Title

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

Official Title

A Randomized, Placebo- And Positive-Controlled Cross-Over Study To Evaluate The Effect Of Tafamidis On The QTC Interval In Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

TTR Cardiomyopathy

Keywords

Thorough QTc evaluation of tafamidis compared to the effects of moxifloxacin and placebo in healthy volunteers.

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Period 1: 960 mg tafamidis (Vyndaqel)

Arm Type

Experimental

Arm Title

Period 2: 400 mg moxifloxacin

Arm Type

Experimental

Arm Description

400 mg moxifloxacin

Arm Title

Period 3: Placebo

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Period 1

Other Intervention Name(s)

tafamidis (Vyndaqel)

Intervention Description

A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval.

Intervention Type

Drug

Intervention Name(s)

Period 2

Other Intervention Name(s)

moxifloxacin

Intervention Description

A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval.

Intervention Type

Drug

Intervention Name(s)

Period 3

Intervention Description

A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval.

Primary Outcome Measure Information:

Title

QTc interval using Fridericia's correction method (QTcF) of tafamidis and placebo (baseline-adjusted) at each post-dose time

Time Frame

SCRN, -1, -0.5, 0, 1, 1.5, 2, 3, 4, 6, 12, 24 hrs

Secondary Outcome Measure Information:

Title

QTcF of moxifloxacin and placebo at historical moxifloxacin median Tmax of 3 hours.

Time Frame

Scrn, -1, -0.5, 0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs

Title

Tmax

Time Frame

0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs

Title

Cmax

Time Frame

0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs

Title

AUC0-24

Time Frame

0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06511

Country

United States

Facility Name

Pfizer Investigational Site

City

Bruxelles

ZIP/Postal Code

B-1070

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Singapore

ZIP/Postal Code

188770

Country

Singapore

12. IPD Sharing Statement

Citations:

PubMed Identifier

25546001

Citation

Klamerus KJ, Watsky E, Moller R, Wang R, Riley S. The effect of tafamidis on the QTc interval in healthy subjects. Br J Clin Pharmacol. 2015 Jun;79(6):918-25. doi: 10.1111/bcp.12561.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3461031&StudyName=A%20Study%20To%20Determine%20Any%20Effect%20Of%20Tafamidis%20On%20Electrocardiographic%20Intervals%2C%20Specifically%20The%20Rate%20Corrected%20QT%20Interval%20%28QTc%29

Description

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

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