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Tafamidis meglumin

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Sep 13, 2011

Tafamidis meglumin development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jun 2011

Tafamidis meglumin target and mechanism

Molecular targetTTR
Target classStabiliser
ModalitySmall molecule

Also known as PF-06291826

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

Tafamidis meglumin clinical trials

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
HealthyUnlock trial analytics

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 an investigational small molecule developed by Pfizer, Inc. (ticker PFE). It is a transthyretin (TTR) stabilizer that has been studied in a Phase 1 clinical trial in healthy volunteers. Its specific therapeutic indication has not been disclosed.

What does tafamidis meglumin target?

Tafamidis meglumin targets transthyretin, also known as TTR. It belongs to the TTR stabilizer class, meaning it is designed to bind and stabilize the TTR protein. This mechanism is distinct from approaches that reduce TTR production.

Who makes tafamidis meglumin?

Tafamidis meglumin is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer conducted the clinical development work for this asset, including the Phase 1 study of single doses in Japanese and Western subjects.

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 the FDA. The only recorded trial for this asset is a completed Phase 1 study, and no active trials are currently listed.

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 volunteers in the United States, was randomized, double-blind, and active-controlled.

Is tafamidis meglumin the same as tafamidis?

Tafamidis meglumin is the meglumine salt form of tafamidis, and the two names refer to the same active substance. The Phase 1 trial NCT01369836 lists the drug as PF-06291826 (Tafamidis), confirming these names identify the same compound.