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A Study To Estimate How Much Tafamidis Created In Different Ways Can Be Measured in Blood Samples

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: NCT02189330
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : July 15, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 15, 2014
First Posted Date  ICMJE July 14, 2014
Last Update Posted Date July 15, 2014
Study Start Date  ICMJE May 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [ Time Frame: 168 hours ]
    AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
  • 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: July 10, 2014)
  • 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: 6 ]
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 To Estimate How Much Tafamidis Created In Different Ways Can Be Measured in Blood Samples
Official Title  ICMJE A Phase 1, Open-Label, Randomized, 2-Cohort, Crossover, Single Dose Study to Estimate the Relative Bioavailability of PF 06291826 (Tafamidis) Following Administration of Two Oral Formulations Versus Commercial Capsule in Healthy Subjects Under Fasted Conditions
Brief Summary All subjects in this study will be given tafamidis. After swallowing a single pill of tafamidis, measurements including blood samples will be compared to see if tafamidis made in different ways is about the same. After approximately 28 days subjects will be given another pill of tafamidis and the study measurements will be repeated.
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
    20 mg of current commercial formulation.
  • Drug: Tafamidis
    12.2 mgA free acid tablet.
  • Drug: Tafamidis
    20 mg new soft gelatin capsule.
  • Drug: Tafamidis
    4 capsules of 20 mg tafamidis of current commercial formulation.
  • Drug: Tafamidis
    4 capsules of 12.2 mg tafamidis of free acid tablet..
Study Arms  ICMJE
  • Experimental: Tafamidis
    Intervention: Drug: Tafamidis
  • Experimental: Tafamudus Free Acid
    Intervention: Drug: Tafamidis
  • Experimental: 20 mg new soft gelatin capsule
    Intervention: Drug: Tafamidis
  • Experimental: 4 capsules of 20 mg tafamidis of commercial formulation
    Intervention: Drug: Tafamidis
  • Experimental: 4 capsules of 12.2 mg tafamidis of free acid tablet
    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: July 10, 2014)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (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 NCT02189330
Other Study ID Numbers  ICMJE B3461030
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 2014

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