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

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.
ClinicalTrials.gov Identifier: NCT01369836
Recruitment Status : Completed
First Posted : June 9, 2011
Last Update Posted : September 13, 2011
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Tafamidis meglumin Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
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
Study Start Date : July 2011
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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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.

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

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01369836     History of Changes
Other Study ID Numbers: B3461009
First Posted: June 9, 2011    Key Record Dates
Last Update Posted: September 13, 2011
Last Verified: September 2011

Keywords provided by Pfizer:
Tafamidis
Pharmacokinetics
TTR stabilization