NCT01775761

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_1

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 25, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

May 21, 2013

Status Verified

May 1, 2013

Enrollment Period

3 months

First QC Date

January 15, 2013

Last Update Submit

May 20, 2013

Conditions

TTR Cardiomyopathy

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

Study Arms (3)

Period 1: 960 mg tafamidis (Vyndaqel)

EXPERIMENTAL
Drug: Period 1

Period 2: 400 mg moxifloxacin

EXPERIMENTAL

400 mg moxifloxacin

Drug: Period 2

Period 3: Placebo

EXPERIMENTAL
Drug: Period 3

Interventions

Period 1DRUG

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

Also known as: tafamidis (Vyndaqel)
Period 1: 960 mg tafamidis (Vyndaqel)
Period 2DRUG

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

Also known as: moxifloxacin
Period 2: 400 mg moxifloxacin
Period 3DRUG

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

Period 3: Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Pfizer Investigational Site

Brussels, B-1070, Belgium

Location

Pfizer Investigational Site

Singapore, Singapore, 188770, Singapore

Location

Related Publications (1)

  • 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.

    PMID: 25546001DERIVED

Related Links

MeSH Terms

Interventions

tafamidisMoxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 25, 2013

Study Start

January 1, 2013

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

May 21, 2013

Record last verified: 2013-05

Locations

US(1)SG(1)BE(1)