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Completed

NCT Number: NCT01369836

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

Completed

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Glendale, California, 91206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tafamidis meglumin

Drug

A single oral dose of 20 mg capsule

Other names: PF-06291826

Placebo

Drug

A single oral dose of matched placebo.

Primary outcomes

  1. Plasma concentration of tafamidis over time (AUClast).

    Time frame: 2 months

  2. Plasma concentration of tafamidis over time (Cmax).

    Time frame: 2 months

  3. Plasma concentration of tafamidis over time (Tmax).

    Time frame: 2 months

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

    Time frame: 2 months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 9, 2011
Registry last updated
Sep 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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