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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01775761
First received: January 15, 2013
Last updated: May 20, 2013
Last verified: May 2013

January 15, 2013
May 20, 2013
January 2013
April 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01775761 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • Tmax [ Time Frame: 0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs ] [ Designated as safety issue: No ]
  • Cmax [ Time Frame: 0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs ] [ Designated as safety issue: No ]
  • AUC0-24 [ Time Frame: 0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Basic Science
TTR Cardiomyopathy
  • Drug: Period 1
    A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval.
    Other Name: tafamidis (Vyndaqel)
  • Drug: Period 2
    A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval.
    Other Name: moxifloxacin
  • Drug: Period 3
    A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval.
  • Experimental: Period 1: 960 mg tafamidis (Vyndaqel)
    Intervention: Drug: Period 1
  • Experimental: Period 2: 400 mg moxifloxacin
    400 mg moxifloxacin
    Intervention: Drug: Period 2
  • Experimental: Period 3: Placebo
    Intervention: Drug: Period 3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
April 2013
April 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Singapore
 
NCT01775761
B3461031
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP