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

September 12, 2011 updated by: Pfizer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Glendale, California, United States, 91206
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Placebo
Drug: Placebo
A single oral dose of matched placebo.
Experimental: 20 mg soft gelatin capsule
Drug: Tafamidis meglumin
A single oral dose of 20 mg capsule
Other Names:
  • PF-06291826
Drug: Tafamidis meglumin
A single oral dose of 40 mg capsule.
Other Names:
  • PF-06291826
Experimental: 40 mg (20 mg*2) soft gelatin capsule
Drug: Tafamidis meglumin
A single oral dose of 20 mg capsule
Other Names:
  • PF-06291826
Drug: Tafamidis meglumin
A single oral dose of 40 mg capsule.
Other Names:
  • PF-06291826

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma concentration of tafamidis over time (AUClast).
Time Frame: 2 months
2 months
Plasma concentration of tafamidis over time (Cmax).
Time Frame: 2 months
2 months
Plasma concentration of tafamidis over time (Tmax).
Time Frame: 2 months
2 months
If data permit, AUCinf and t1/2 will be determined.
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The percent stabilization of TTR tetramer will be defined at Cmax in each subject and compared between Japanese volunteers and Western volunteers.
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

June 6, 2011

First Submitted That Met QC Criteria

June 7, 2011

First Posted (Estimate)

June 9, 2011

Study Record Updates

Last Update Posted (Estimate)

September 13, 2011

Last Update Submitted That Met QC Criteria

September 12, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B3461009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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