A Study To Determine Any Effect Of Tafamidis On Electrocardiographic Intervals, Specifically The Rate Corrected QT Interval (QTc)
NCT ID: NCT01775761
Last Updated: 2013-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
42 participants
INTERVENTIONAL
2013-01-31
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Period 1: 960 mg tafamidis (Vyndaqel)
Period 1
A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval.
Period 2: 400 mg moxifloxacin
400 mg moxifloxacin
Period 2
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
Period 3
A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval.
Interventions
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Period 1
A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval.
Period 2
A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval.
Period 3
A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
* Total body weight \>50 kg (110 lbs).
Exclusion Criteria
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
New Haven, Connecticut, United States
Pfizer Investigational Site
Brussels, , Belgium
Pfizer Investigational Site
Singapore, Singapore, Singapore
Countries
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References
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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.
Related Links
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Other Identifiers
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B3461031
Identifier Type: -
Identifier Source: org_study_id
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