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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional relevant MeSH terms:
Meglumine
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014