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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01775761
Enrollment
42
Registered
2013-01-25
Start date
2013-01-31
Completion date
2013-04-30
Last updated
2013-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TTR Cardiomyopathy

Keywords

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

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.

Interventions

DRUGPeriod 1

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

DRUGPeriod 2

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

DRUGPeriod 3

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

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
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
Tmax0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs
Cmax0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs
AUC0-240, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs

Countries

Belgium, Singapore, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026