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PF-06700841 IR

Phase 1

Healthy Participants | Small molecule | Other |Pfizer, Inc.|Last Updated: Mar 8, 2021

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 Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04580797Clinical Study to Evaluate Pharmacokinetics and Safety of PF-06700841 After Single and Multiple Oral Doses as Modified Release FormulationsPHASE1 COMPLETED 36 — — Oct 2, 2020Jan 11, 2021Mar 8, 20212 United States
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Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part A
pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose
Area under the plasma concentration-time curve from time zero to the last measured concentration (AUClast) of PF-06700841 in Part A
pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose
Area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUCinf) of PF-06700841 if data permit in Part A
pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose
Time to reach maximum observed plasma concentration (Tmax) of PF-06700841 in Part A
pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose
Number of participants with Treatment- Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation due to AEs in Part B
Baseline to Day 10
Secondary Endpoints
Number of subjects with clinically relevant changes in Electrocardiogram (ECG) parameters in Part A
Pre-dose and 96 hours post dose
Number of subjects with clinically relevant changes in vital signs in Part A
Pre-dose and 96 hours post dose
Number of participants with clinically relevant changes in clinical laboratory tests in Part A
Baseline and 96 hours post dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
PF-06700841: IR, MR1, MR2, MR1_fedEXPERIMENTALParticipants receive single doses of immediate release (IR) followed by modified release (MR) MR1 and MR2, all in fasted condition followed by MR1 in fed condition in Periods 1-4
PF-06700841: MR1, MR2, IR, MR1_fedEXPERIMENTALParticipants receive single doses of MR1 followed by MR2 and IR, all in fasted condition followed by MR1 in fed condition in Periods 1-4
PF-06700841: MR2, IR, MR1, MR1_fedEXPERIMENTALParticipants receive single doses of MR2 followed by IR and MR1, all in fasted condition followed by MR1 in fed condition in Periods 1-4
PF-06700841: IR, MR1, MR2, MR2_fedEXPERIMENTALParticipants receive single doses of IR followed by MR1 and MR1, all in fasted condition followed by MR2 in fed condition in Periods 1-4
PF-06700841: MR1, MR2, IR, MR2_fedEXPERIMENTALParticipants receive single doses of MR1 followed by MR2 and IR, all in fasted condition followed by MR2 in fed condition in Periods 1-4
PF-06700841: MR2, IR, MR1, MR2_fedEXPERIMENTALParticipants receive single doses of MR2 followed by IR and MR1, all in fasted condition followed by MR2 in fed condition in Periods 1-4
PF-06700841 MR3 (Dose A) or matching placeboEXPERIMENTALParticipants receive dosing regimen 1 of MR3 (Dose A) or matching placebo for 7 days under fasted condition
PF-06700841 MR3 (Dose B) or matching placeboEXPERIMENTALParticipants receive dosing regimen 1 of MR3 (Dose B) or matching placebo for 7 days under fasted condition
PF-06700841 MR3 (Dose C) or matching placeboEXPERIMENTALParticipants receive dosing regimen 1 of MR3 (Dose C) or matching placebo for 7 days under fasted condition
Interventions
NameTypeDescription
PF-06700841 IRDRUGImmediate release formulation
PF-06700841 MR1DRUGModified release formulation 1
PF-06700841 MR2DRUGModified release formulation 2
PF-06700841 MR3DRUGModified release formulation 3
PlaceboOTHERMatching placebo
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Healthy male and female participants between 18 -55 years of age. * BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb). * Participants who are willing and able to comply with all scheduled visits, treatment * plan, laboratory tests, lifestyle considerations, a...

Countries:United States
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