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

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NCT02534740

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Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070, Belgium
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Comparing Amounts of Tafamidis In The Blood With Or Without Food
Official Title  ICMJE A Phase 1, Open-Label, Randomized, Single Dose Study To Estimate The Relative Bioavailability And Food Effect Of PF?06291826 (Tafamidis) Following Administration Of New Soft Gelatin Capsule Oral Formulations In Healthy Subjects
Brief Summary This is a 2 part study. In part 1 of the study, 3 different formulations of the same dose 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. In part 2 of the study, depending on the results of part 1, either none, one or 2 of the formulations tested in part 1 will be tested comparing the same formulation when given either with or without food. Additionally, depending on the results of part 1 of the study, different doses of the formulations may be compared.
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
    relative bioavailability
  • Drug: tafamidis
    fasted
  • Drug: tafamidis
    fed
Study Arms  ICMJE
  • Experimental: 4 soft gel capsules of 20 mg tafamidis meglumine
    Intervention: Drug: tafamidis
  • Experimental: 48.8 mg tafamidis soft gel capsule formulation 1
    Interventions:
    • Drug: tafamidis
    • Drug: tafamidis
  • Experimental: 48.8 mg tafamidis soft get capsule formulation 2
    Interventions:
    • Drug: tafamidis
    • Drug: tafamidis
  • Experimental: 61 mg tafamidis soft gel capsule formulation 1
    Intervention: Drug: tafamidis
  • Experimental: 61 mg tafamidis soft gel capsule formulation 2
    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: October 2, 2015)		18
Original Estimated Enrollment  ICMJE
 (submitted: August 25, 2015)		30
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 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.
  • 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 NCT02534740
Other Study ID Numbers  ICMJE B3461052
2015-002315-15 ( 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 December 2015

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