A Study To Determine Any Effect Of Tafamidis On Electrocardiographic Intervals, Specifically The Rate Corrected QT Interval (QTc)
NCT01775761
ABOUT THIS STUDY
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- 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).
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | A Study To Determine Any Effect Of Tafamidis On Electrocardiographic Intervals, Specifically The Rate Corrected QT Interval (QTc) | |||
Official Title ICMJE | A Randomized, Placebo- And Positive-Controlled Cross-Over Study To Evaluate The Effect Of Tafamidis On The QTC Interval 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double (Participant, Care Provider) Primary Purpose: Basic Science | |||
Condition ICMJE | TTR Cardiomyopathy | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 42 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | April 2013 | |||
Actual Primary Completion Date | April 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, Singapore, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01775761 | |||
Other Study ID Numbers ICMJE | B3461031 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | May 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |