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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT01369836
Collaborator
(none)
21
Enrollment
1
Location
3
Arms
1
Duration (Months)
20.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tafamidis meglumin
  • Drug: Tafamidis meglumin
  • Drug: Placebo
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
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
Study Start Date :
Jul 1, 2011
Actual Primary Completion Date :
Aug 1, 2011
Actual Study Completion Date :
Aug 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: 20 mg soft gelatin capsule

Drug: Tafamidis meglumin
A single oral dose of 20 mg capsule
Other Names:
  • PF-06291826

    		•
    Experimental: 40 mg (20 mg*2) soft gelatin capsule

    Drug: Tafamidis meglumin
    A single oral dose of 40 mg capsule.
    Other Names:
  • PF-06291826

    		•
    Active Comparator: Placebo

    Drug: Placebo
    A single oral dose of matched placebo.

    Outcome Measures

    Primary Outcome Measures

    1. Plasma concentration of tafamidis over time (AUClast). [2 months]

    2. Plasma concentration of tafamidis over time (Cmax). [2 months]

    3. Plasma concentration of tafamidis over time (Tmax). [2 months]

    4. If data permit, AUCinf and t1/2 will be determined. [2 months]

    Secondary Outcome Measures

    1. The percent stabilization of TTR tetramer will be defined at Cmax in each subject and compared between Japanese volunteers and Western volunteers. [2 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Glendale California United States 91206

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT01369836
    Other Study ID Numbers:
    • B3461009
    First Posted:
    Jun 9, 2011
    Last Update Posted:
    Sep 13, 2011
    Last Verified:
    Sep 1, 2011
    Keywords provided by Pfizer
    Tafamidis
    Pharmacokinetics
    TTR stabilization

    Study Results

    No Results Posted as of Sep 13, 2011