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PF-04629991

Phase 1

Healthy Volunteers | Small molecule | Other |Pfizer, Inc.|Last Updated: May 5, 2009

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-BlindCONTROLLED
Total Trials1
Total Enrollment27
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00797342A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04629991 in Healthy VolunteersPHASE1 COMPLETED 27 — — Dec 1, 2008Apr 1, 2009May 5, 20091 Belgium
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Study Endpoints
Primary Endpoints
Pharmacokinetics e.g., maximum concentration and area under the concentration-time curve
2 weeks
Safety/Tolerability e.g., reported adverse events and safety laboratory studies
2 weeks
Pharmacodynamics e.g., changes in a peripheral blood biomarker
2 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
first of three dosing cohortsOTHER -
second of three dosing cohortsOTHER -
third of three dosing cohortsOTHER -
Interventions
NameTypeDescription
PF-04629991DRUGOral; Sequential single dose escalation; three fourteen-day treatment periods per subject in the first cohort; randomized sequence of treatments (one placebo and two PF-04629991 doses)
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy non-smoking men and women * body mass index 18-30 kg/m2 Exclusion Criteria: * Women must not be able to have children * no current infections

Countries:Belgium
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