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Trial record 1 of 1 for:    NCT02406560
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A Study Comparing The Amounts of Tafamidis In The Blood With Or Without Food

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ClinicalTrials.gov Identifier: NCT02406560
Recruitment Status : Completed
First Posted : April 2, 2015
Last Update Posted : August 7, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE March 30, 2015
First Posted Date  ICMJE April 2, 2015
Last Update Posted Date August 7, 2015
Study Start Date  ICMJE April 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2015)
  • Area under the Concentration-Time Curve (AUC) [ Time Frame: 168 hours ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 168 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2015)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 168 hours ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 168 hours ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: 168 hours ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
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