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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01369836

Enrollment

Registered

2011-06-09

Start date

2011-07-31

Completion date

2011-08-31

Last updated

2011-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Tafamidis, Pharmacokinetics, TTR stabilization

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.

Interventions

DRUGTafamidis meglumin

A single oral dose of 20 mg capsule

DRUGPlacebo

A single oral dose of matched placebo.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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.

Design outcomes

Primary

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

Secondary

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.	2 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026