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

TTR Cardiomyopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01775761
• Other study ID #: B3461031
• Status: Completed
• Phase: Phase 1
• First received: January 15, 2013
• Last updated: May 20, 2013
• Start date: January 2013
• Est. completion date: April 2013

Study information

• Verified date: May 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiomyopathies
• TTR Cardiomyopathy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles
Singapore	Pfizer Investigational Site	Singapore
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Belgium,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QTc interval using Fridericia's correction method (QTcF) of tafamidis and placebo (baseline-adjusted) at each post-dose time		SCRN, -1, -0.5, 0, 1, 1.5, 2, 3, 4, 6, 12, 24 hrs	Yes
Secondary	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	Yes
Secondary	Tmax		0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs	No
Secondary	Cmax		0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs	No
Secondary	AUC0-24		0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs	No

External Links

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