A Study Comparing The Amounts of Tafamidis In The Blood With Or Without Food

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NCT02406560

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Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070, Belgium
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1-800-718-1021
[email protected]
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Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
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- Healthy males or females of non-child bearing potential. - Body Mass Index (BMI) of 17.5 to 30.5 and total body weight more than 50 kg (110 lbs).

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Blood pressure at screening visit of greater than 140 mm Hg
(systolic) or 90 mg Hg (diastolic). - Use of prescription or nonprescription drugs
supplements within 7 days prior to 7 days of the study.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Comparing The Amounts of Tafamidis In The Blood With Or Without Food
Official Title  ICMJE A Phase 1, Open-label, Randomized, Crossover, Oral, Single Dose Study To Estimate The Relative Bioavailability Of Pf-06291826 (Tafamidis) Following Administration Of A Tafamidis Free Acid Tablet Formulation In Healthy Subjects Under Fasted And Fed Conditions
Brief Summary Each subject will be given tafamidis after either a high fat meal or while fasted. After swallowing tafamidis, tafamidis blood concentrations will be measured periodically for one week. After about 14 days, subjects will take either a different dose of tafamidis or the same dose under the opposite meal condition. Tafamidis concentrations from the three different conditions will be compared to determine if they are approximately the same.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: tafamidis
    fasted
  • Drug: tafamidis
    high fat meal
  • Drug: tafamidis
    Other Name: fasted
Study Arms  ICMJE
  • Experimental: 4 tablets of 12.2 mg tafamdis free acid
    Intervention: Drug: tafamidis
  • Experimental: 4 tablets of 12.2 mg tafamidis free acid
    Intervention: Drug: tafamidis
  • Experimental: 5 tablets of 12.2 mg tafamidis free acid
    Intervention: Drug: tafamidis
Publications * Not Provided

*   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
 (submitted: March 30, 2015)		12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: - Healthy males or females of non-child bearing potential. - Body Mass Index (BMI) of 17.5 to 30.5 and total body weight more than 50 kg (110 lbs).

Exclusion Criteria: - Blood pressure at screening visit of greater than 140 mm Hg (systolic) or 90 mg Hg (diastolic). - Use of prescription or nonprescription drugs supplements within 7 days prior to 7 days of the study.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02406560
Other Study ID Numbers  ICMJE B3461050
2015-000706-19 ( EudraCT Number )
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
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2015

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