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PF-04308515

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Jul 25, 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 Trials2
Total Enrollment76
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01199029Single Dose Study Of PF-04308515 And Prednisone On CarbohydratePHASE1 COMPLETED 18 — — Aug 1, 2010Sep 1, 2010Dec 16, 20101 United States
NCT01101932Multiple Dose Escalation Trial Of PF-04308515 In Healthy VolunteersPHASE1 COMPLETED 58 — — Mar 1, 2010Nov 1, 2010Jul 25, 20111 United States
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Study Endpoints
Primary Endpoints
Fold change in AUC (0-4hr) relative to no treatment baseline for plasma glucose, plasma insulin and plasma C-peptide
4 hours
Safety and tolerability of multiple doses of PF-04308515 as assessed by adverse event reporting, clinical laboratory results, vital signs, physical examinations and electrocardiograms (ECGs).
14 days
Characterization of pharmacokinetic parameters of PF-04308515 after multiples doses which will include: Cmax, Tmax, AUC, CL/F, Vz/F, t1/2. Urinary excretion including AE% and CLr will be assessed at steady state.
14 days
Change from baseline will be utilized to assess PF-04308515's pharmacodynamic effect on biochemical and metabolic biomarkers after 14 days of dosing.
14 days
For the tablet pharmacokinetics:Cmax, Tmax, AUClast, AUCinf, CL/F, Vz/F, t1/2 will be calculated from the PF-04308515 plasma concentration versus time data.
1 day
Safety and tolerability of 1 oral dose of a tablet formulation of PF-04308515 as assessed by adverse event reporting, clinical laboratory results, vital signs, physical examinations and electrocardiograms (ECGs).
1 day
Secondary Endpoints
Pharmacodynamic effects on plasma glucose, plasma insulin, and plasma C-peptide
3 days
Safety: adverse events, vital sign measurements, physical examination
3 days
Pharmacokinetics: sparse PF-04308515 plasma samples will be collected
3 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
(Part 1) 10 mg PF-04308515 (8hrs)EXPERIMENTAL -
(Part 1) 10 mg PF-04308515 (12hrs)EXPERIMENTAL -
(Part 1) 5 mg PrednisoneACTIVE_COMPARATOR -
(Part 2) X mg PF-04308515EXPERIMENTAL -
(Part 2) Y mg PF-04308515EXPERIMENTAL -
(Part 2) 5 mg PrednisoneACTIVE_COMPARATOR -
(Part 2) 20 mg PrednisoneACTIVE_COMPARATOR -
(Part 1) PF-04308515EXPERIMENTAL -
(Part 1) Solution PlaceboPLACEBO_COMPARATOR -
(Part 2) PF-04308515 TabletEXPERIMENTAL -
Interventions
NameTypeDescription
PF-04308515DRUG10 mg extemporaneous preparation of oral solution predosed 8 hours prior to Oral Glucose Tolerance Test(OGTT)
PrednisoneDRUG5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)
PlaceboDRUGPlacebo solution will be administered to those volunteers who are randomized to the placebo arm. Placebo solution will be administered orally once daily for 14 days.
PF-04308515 TabletDRUGTablet formulation to administer a 20 mg dose will be administered to volunteers in Part 2. The study medication will be administered orally once daily for 1 day.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * BMI 17.5 to 30.5 kg/m2 and total body weight \>50 kg Exclusion Criteria: * Fasting glucose above the limits of the reference range for healthy individuals * "No treatment" OGTT indicative of impaired fasting glucose or impaired glucose tolerance * Severe acute or chronic med...

Countries:United States
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