Study Of Single Doses Of PF-06291826 (Tafamidis) In Japanese And Western Subjects
- Registration Number
- NCT01369836
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 20 mg soft gelatin capsule Tafamidis meglumin - 40 mg (20 mg*2) soft gelatin capsule Tafamidis meglumin - Placebo Placebo -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method The percent stabilization of TTR tetramer will be defined at Cmax in each subject and compared between Japanese volunteers and Western volunteers. 2 months
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Glendale, California, United States