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Tafamidis meglumin

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Sep 13, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

Tafamidis meglumin · 1 trial · 1 indication

Phase 1 1
NCT01369836Study Of Single Doses Of PF-06291826 (Tafamidis) In Japanese And Western SubjectsHealthy
COMPLETED21 Analytics
PHASE1COMPLETED
Study Of Single Doses Of PF-06291826 (Tafamidis) In Japanese And Western Subjects
Healthy
NCT0136983621
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Study Endpoints

Primary Endpoints

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 Endpoints

The percent stabilization of TTR tetramer will be defined at Cmax in each subject and compared between Japanese volunteers and Western volunteers.
2 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
20 mg soft gelatin capsuleEXPERIMENTAL -
40 mg (20 mg*2) soft gelatin capsuleEXPERIMENTAL -
PlaceboACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Tafamidis megluminDRUGA single oral dose of 20 mg capsule
PlaceboDRUGA single oral dose of matched placebo.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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.

Countries:United States
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Frequently asked questions about Tafamidis meglumin

What is Tafamidis meglumin?

Tafamidis meglumin is a small molecule drug being developed by Pfizer, Inc. It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, with one completed trial involving 21 participants.

What is Tafamidis meglumin used for?

Tafamidis meglumin is being studied for use in healthy volunteers. It is an investigational drug in Phase 1 clinical development, and its intended therapeutic use has not been established beyond the research setting.

Who makes Tafamidis meglumin?

Tafamidis meglumin is developed by Pfizer, Inc., a company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development.

What phase is Tafamidis meglumin in?

Tafamidis meglumin is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed.

What clinical trials is Tafamidis meglumin in?

Tafamidis meglumin has been studied in one completed Phase 1 trial, NCT01369836, titled "Study Of Single Doses Of PF-06291826 (Tafamidis) In Japanese And Western Subjects." The trial enrolled 21 healthy participants in the United States.

Is Tafamidis meglumin the same as PF-06291826?

Yes, Tafamidis meglumin is also known as PF-06291826. The completed Phase 1 trial NCT01369836 used the name PF-06291826 to refer to the drug.