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Study Of Single Doses Of PF-06291826 (Tafamidis) In Japanese And Western Subjects

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NCT01369836

Last updated on May 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Glendale, California, 91206 United States
See other locations
Contact
1-800-718-1021
[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 male or females.

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Pregnant or nursing females.

- Females of childbearing potential who are unwilling or unable to use an acceptable
method of contraception.

NCT01369836
Pfizer
Completed
Study Of Single Doses Of PF-06291826 (Tafamidis) In Japanese And Western Subjects

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Study Of Single Doses Of PF-06291826 (Tafamidis) In Japanese And Western Subjects
An Investigator And Subject-Blind Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-06291826 (Tafamidis) After Single Oral Administration To Japanese And Western Healthy Subjects

The purpose of this study is the following:

  • To evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered tafamidis in Japanese and Western healthy volunteers at single dose.
  • To compare Japanese and Western PK profiles.
  • Determine the PD stabilization effect of tafamidis on human transthyretin (TTR) in a validated ex vivo assay.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Healthy
  • Drug: Tafamidis meglumin
    A single oral dose of 20 mg capsule
    Other Name: PF-06291826
  • Drug: Tafamidis meglumin
    A single oral dose of 40 mg capsule.
    Other Name: PF-06291826
  • Drug: Placebo
    A single oral dose of matched placebo.
    Other Name: Not Specified
  • Experimental: 20 mg soft gelatin capsule
    Intervention: Drug: Tafamidis meglumin
  • Experimental: 40 mg (20 mg*2) soft gelatin capsule
    Intervention: Drug: Tafamidis meglumin
  • Active Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
August 2011
August 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male or females.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.

Exclusion Criteria:

  • Pregnant or nursing females.
  • Females of childbearing potential who are unwilling or unable to use an acceptable 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
 
 
NCT01369836
B3461009
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2011

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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1-800-718-1021

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[email protected]



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