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

Pfizer21 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

Tafamidis megluminDRUG

A single oral dose of 20 mg capsule

Tafamidis megluminDRUG

A single oral dose of 40 mg capsule.

PlaceboDRUG

A single oral dose of matched placebo.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Investigational Site

Glendale, California, United States

Outcomes

Primary Outcomes

Plasma concentration of tafamidis over time (AUClast).

Time frame: 2 months

Plasma concentration of tafamidis over time (Cmax).

Time frame: 2 months

Plasma concentration of tafamidis over time (Tmax).

Time frame: 2 months

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

Time frame: 2 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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