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A Study Comparing Amounts of Tafamidis In The Blood Without Food

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02697864
Recruitment Status : Completed
First Posted : March 3, 2016
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE February 29, 2016
First Posted Date  ICMJE March 3, 2016
Last Update Posted Date July 24, 2017
Actual Study Start Date  ICMJE April 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 29, 2016)
  • Area under the concentration-time Curve (AUC) [ Time Frame: 120 hours ]
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 120 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 29, 2016)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 120 hours ]
  • Mean residence time (MRT) [ Time Frame: 120 hours ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 120 hours ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: 120 hours ]
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 Amounts of Tafamidis In The Blood Without Food
Official Title  ICMJE A Phase 1, Open‑Label, Three Period Randomized, Single Dose Study To Estimate The Relative Bioavailability Of Pf‑06291826 (Tafamidis) Free Acid Tablet Formulation Versus Commercial Capsule In Healthy Subjects Under Fasted Conditions
Brief Summary 3 different formulations and doses of tafamidis will be compared. Subjects will be fasted for each test and every subject will test all 3 different formulations. After swallowing tafamidis, tafamidis blood concentrations will be measured periodically for 6 days. After 14 days, subjects will take a different formulation of tafamidis and tafamidis blood concentrations will be measured periodically for 6 days. After another 14 days, the last formulation will be tested in the same way.
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
Intervention  ICMJE Drug: tafamidis
Study Arms  ICMJE
  • Experimental: 48.8 mgA tafamidis free acid tablet
    Intervention: Drug: tafamidis
  • Experimental: 58 mgA tafamidis free acid tablet
    Intervention: Drug: tafamidis
  • Experimental: 4 soft gel capsules of 20 mg tafamidis meglumine
    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: February 29, 2016)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (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.
  • Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception.
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 NCT02697864
Other Study ID Numbers  ICMJE B3461051
2016-000295-16 ( 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 July 2017

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