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PF-04620110

Phase 1

Obesity | Small molecule | Metabolic |Pfizer, Inc.|Last Updated: Jun 7, 2010

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment71
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00959426A Multiple Dose Study Of PF-04620110 In Overweight And Obese, Otherwise Healthy VolunteersPHASE1 COMPLETED 71Aug 1, 2009May 1, 2010Jun 7, 20101 United States
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Study Endpoints
Primary Endpoints
To assess safety and tolerability of PF-04620110 will be assessed by physical examinations, adverse event monitoring, 12-lead ECGs, vital sign, andc linical safety laboratory measurements.
Baseline to 2 weeks
To characterize the PK of PF-04620110 following multiple oral doses in otherwise healthy overweight and obese subjects.
Baseline to 2 weeks
To characterize the effect of PF-04620110 on postprandial lipid metabolism measures.
Baseline to 2 weeks
Secondary Endpoints
To examine additional pharmacodynamic markers in response to multiple oral doses of PF-04620110.
Day -1 and Day 14
Secondary Pharmacodynamic Endpoints in response to a liquid meal test
Day -1 and Day 14
Triglyceride excursions
Day -1, Day 1, and Day 14
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PF-04620110EXPERIMENTAL -
Placebo ComparatorPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
PF-04620110DRUGMultiple oral doses of PF-04620110 will be given. The specific dose will depend on the cohort to which the subject is assigned Initial planned doses are 1, 3, 5, 10 and 20 mg but may be modified based on emerging PK and safety data.
PlaceboDRUGSubjects will be given placebo or PF-04620110. Anticipated total daily doses for Cohorts A, B, C, D, E, F and G are 1, 3, 5, 10 and 20 mg. In each Cohort 9 subjects will receive active treatment and 3 will receive placebo for 14 days. Doses shown may be adjusted upwards or downwards and may be adjusted to include intermediate doses during the study based on ongoing safety, tolerability and PK results, but will not be projected to exceed established PK stopping criteria.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects between the ages of 18 and 55 years * Body Mass Index (BMI) of 26.5 to 35.5 kg/m2; and a total body weight \>50 kg (110 lbs). Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, g...

Countries:United States
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