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PF-06882961 Immediate Release

Phase 1

Healthy Subjects | Small molecule | Other |Pfizer, Inc.|Last Updated: Jul 30, 2018

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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03492697A Single Dose Crossover Study In Healthy Subjects To Evaluate Different Formulations Of PF-06882961PHASE1 COMPLETED 12 — — Apr 30, 2018Jul 18, 2018Jul 30, 20181 United States
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Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax) for PF-06882961
0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period
Time to Maximum Observed Plasma Concentration (Tmax) for PF-06882961
0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period
Area under the curve from time zero to last quantifiable concentration for PF-06882961 (AUClast)
0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period
Area under the curve from time zero to extrapolated infinite time for PF-06882961 (AUCinf), as data permit
0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period

AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).

Observed Plasma Concentration for PF-06882961 at 24 hours post-dose (C24)
24 hours post dose in each period
Plasma Decay Half-Life (t1/2) for PF-06882961, as data permit
0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Apparent clearance (CL/F) for PF-06882961, as data permit
0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period

Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Calculated as Dose/AUCinf

Peak-to-trough (PTR) ratio for PF-06882961
0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period

Calculated as ratio of Cmax to C24

Secondary Endpoints
Number of subjects with treatment-emergent adverse events (AEs)
Baseline to at least 28 days after last dose
AUClast for PF-06882961 for CR tablet (long) and IR tablet in fed state
0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose
AUCinf for PF-06882961 for CR tablet (long) and IR tablet in fed state, as data permit
0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
PF-06882961EXPERIMENTAL -
Interventions
NameTypeDescription
PF-06882961 Immediate Release TabletDRUGImmediate Release Tablet
PF-06882961 Controlled Release Tablet (long)DRUGControlled Release tablet (long)
PF-06882961 Controlled Release Tablet (short)DRUGControlled Release tablet (short)
PF-06882961 Immediate Release SolutionDRUGPF-06882961 Immediate Release solution
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive * Body mass index (BMI) within 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb) * Evidence of a personally si...

Countries:United States
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