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PH-797804 material sparing

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Mar 10, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01226693A Study In Healthy Volunteers To Assess The Safety, Tolerability, And Relative Oral Bioavailability Of Three Formulations Of PH-797804PHASE1 COMPLETED 18Nov 1, 2010Mar 1, 2011Mar 10, 20111 Singapore
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Study Endpoints
Primary Endpoints
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)
predose to day 7 of treatment period
Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast)
predose to day 7 of treatment period
Maximum observed concentration within the dosing interval (Cmax)
predose to day 7 of treatment period
Time for Cmax (Tmax)
predose to day 7 of treatment period
Terminal half-life (t1/2)
predose to day 7 of treatment period
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Sequence 1EXPERIMENTAL -
Sequence 2EXPERIMENTAL -
Sequence 3EXPERIMENTAL -
Sequence 4EXPERIMENTAL -
Sequence 5EXPERIMENTALoral, 6mg, single dose
Sequence 6EXPERIMENTALoral, 6mg, single dose
Interventions
NameTypeDescription
PH-797804 material sparing tabletDRUGoral, 6mg, single dose
PH-797804 Phase2b/3 with sodium lauryl sulphateDRUGoral, 6mg, single dose
PH-797804 Phase2b/3 without sodium lauryl sulphateDRUGoral, 6mg, single dose
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Eligibility Criteria
Age Range21 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female subjects of non-childbearing potential between the ages of 21 and 55. * No evidence of active or latent TB. * An informed consent document signed and dated by the subject. Exclusion Criteria: * Evidence, including abnormal clinical laboratory paramete...

Countries:Singapore
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