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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01369836
First Posted: June 9, 2011
Last Update Posted: September 13, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Plasma concentration of tafamidis over time (AUClast). [ Time Frame: 2 months ]
  • Plasma concentration of tafamidis over time (Cmax). [ Time Frame: 2 months ]
  • Plasma concentration of tafamidis over time (Tmax). [ Time Frame: 2 months ]
  • If data permit, AUCinf and t1/2 will be determined. [ Time Frame: 2 months ]

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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01369836     History of Changes
Other Study ID Numbers: B3461009
First Submitted: June 6, 2011
First Posted: June 9, 2011
Last Update Posted: September 13, 2011
Last Verified: September 2011

Keywords provided by Pfizer:
Tafamidis
Pharmacokinetics
TTR stabilization