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A Study Comparing Amounts of Tafamidis (PF‑06291826) in the Blood Without Food in Healthy Volunteers

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NCT02746926

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511 United States
See other locations
Contact
1-800-254-6398
[email protected]
Related Links
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.

NCT02746926
Pfizer
Completed
A Study Comparing Amounts of Tafamidis (PF‑06291826) in the Blood Without Food in Healthy Volunteers

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Pfizer Clinical Trials Contact Center

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A Study Comparing Amounts of Tafamidis (PF?06291826) in the Blood Without Food in Healthy Volunteers
A Phase 1, Open?Label, Three?Period Randomized, Single Dose Study To Estimate The Relative Bioavailability Of Pf?06291826 (Tafamidis) Free Acid Capsule Formulation Versus Commercial Capsule In Healthy Subjects Under Fasted Conditions
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 8 days. After 14 days, subjects will take a different formulation of tafamidis and tafamidis blood concentrations will be measured periodically for 8 days. After another 14 days, the last formulation will be tested in the same way.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
Drug: tafamidis
  • Experimental: 4x20 mg tafamidis meglumine soft gel capsule
    Intervention: Drug: tafamidis
  • Experimental: 48.8 mgA tafamidis free acid capsule
    Intervention: Drug: tafamidis
  • Experimental: 61 mgA tafamidis free acid capsule
    Intervention: Drug: tafamidis
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
July 15, 2016
July 15, 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02746926
B3461053
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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