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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Tafamidis meglumin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01369836

B3461009

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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21 participants in 3 patient groups

20 mg soft gelatin capsule

Experimental group

Treatment:

Drug: Tafamidis meglumin

Drug: Tafamidis meglumin

40 mg (20 mg*2) soft gelatin capsule

Experimental group

Treatment:

Drug: Tafamidis meglumin

Drug: Tafamidis meglumin

Placebo

Active Comparator group

Treatment:

Drug: Placebo