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
  Purpose

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.


Condition Intervention Phase
TTR Cardiomyopathy
Drug: Period 1
Drug: Period 2
Drug: Period 3
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Basic Science
Official Title: A Randomized, Placebo- And Positive-Controlled Cross-Over Study To Evaluate The Effect Of Tafamidis On The QTC Interval In Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 42
Study Start Date: January 2013
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Period 1: 960 mg tafamidis (Vyndaqel) 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)
Experimental: Period 2: 400 mg moxifloxacin
400 mg moxifloxacin
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
Experimental: Period 3: Placebo 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01775761

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, B-1070
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01775761     History of Changes
Other Study ID Numbers: B3461031
Study First Received: January 15, 2013
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Thorough QTc evaluation of tafamidis compared to the effects of moxifloxacin and placebo in healthy volunteers.

Additional relevant MeSH terms:
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2014