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Completed

NCT Number: NCT01775761

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

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.

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Key information

Conditions

TTR Cardiomyopathy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Period 1

Drug

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

Other names: tafamidis (Vyndaqel)

Period 2

Drug

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

Other names: moxifloxacin

Period 3

Drug

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

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Tmax

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

  3. Cmax

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

  4. AUC0-24

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 25, 2013
Registry last updated
May 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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