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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01369836
First received: June 6, 2011
Last updated: September 12, 2011
Last verified: September 2011
  Purpose

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.

Condition Intervention Phase
Healthy
Drug: Tafamidis meglumin
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Plasma concentration of tafamidis over time (AUClast). [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Plasma concentration of tafamidis over time (Cmax). [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Plasma concentration of tafamidis over time (Tmax). [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • If data permit, AUCinf and t1/2 will be determined. [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: July 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 20 mg soft gelatin capsule Drug: Tafamidis meglumin
A single oral dose of 20 mg capsule
Other Name: PF-06291826
Experimental: 40 mg (20 mg*2) soft gelatin capsule Drug: Tafamidis meglumin
A single oral dose of 40 mg capsule.
Other Name: PF-06291826
Active Comparator: Placebo Drug: Placebo
A single oral dose of matched placebo.
Other Name: Not Specified

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01369836

Locations
United States, California
Pfizer Investigational Site
Glendale, California, United States, 91206
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01369836     History of Changes
Other Study ID Numbers: B3461009
Study First Received: June 6, 2011
Last Updated: September 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Tafamidis
Pharmacokinetics
TTR stabilization

ClinicalTrials.gov processed this record on April 17, 2014