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Tafamidis meglumin

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment21
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01369836Study Of Single Doses Of PF-06291826 (Tafamidis) In Japanese And Western SubjectsPHASE1 COMPLETED 21 — — Jul 1, 2011Aug 1, 2011Sep 13, 20111 United States
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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 — 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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