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PF-06650833 alone

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: May 20, 2020

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment15
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03827668A DRUG-DRUG INTERACTION STUDY BETWEEN PF-06650833 AND PF-06651600 FOLLOWING MULTIPLE DOSES IN HEALTHY PARTICIPANTSPHASE1 COMPLETED 15Feb 7, 2019Apr 29, 2019May 20, 20201 United States
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Study Endpoints
Primary Endpoints
PF-06650833 Cmax
Fold-change from Period 1/Day 5 to Period 2/Day 12

Maximum observed concentration (Cmax) derived from plasma

PF-06650833 AUCtau
Fold-change from Period 1/Day 5 to Period 2/Day 12

Area under the plasma concentration-time profile derived from plasma from time 0 to time tau, the dosing interval (AUCtau), where tau=24 for QD dosing.

PF-06651600 Cmax
Fold-change from Period 2/Day 7 to Period 2/Day 12

Maximum observed concentration (Cmax) derived from plasma

PF-06651600 AUCtau
Fold-change from Period 2/Day 7 to Period 2/Day 12

Area under the plasma concentration-time profile derived from plasma from time 0 to time tau, the dosing interval (AUCtau), where tau=24 for QD dosing.

Secondary Endpoints
Percentage of participants with treatment emergent adverse events
From screening until follow-up phone call that takes place 28-35 days after last study dose (total period of approximately 87 days)
Percentage of participants with clinical laboratory test results above/below certain threshold
At screening; Days -1, 6 in Period 1; and Days -1, 8, 9, 11, 13 in Period 2
Percentage of participants with vital signs above/below certain threshold
At screening; Days 1, 6 in Period 1; and Days 1, 8, 9, 12, 13 in Period 2
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Single armEXPERIMENTALThe study will have only one study group in a fixed-sequence type of design with two periods
Interventions
NameTypeDescription
PF-06650833 aloneDRUGIn Period 1, Days 1-5, participants will receive PF-06650833 once daily alone.
PF-06651600 aloneDRUGIn Period 2, Days 1-7, participants will receive PF-06651600 once daily alone.
PF-06650833 together with PF-06651600DRUGIn Period 2, Days 8-12, participants will receive PF-06650833 once daily together with PF-06650833 once daily.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD) * Male and female participants who are healthy as determined by medical evaluation including medical history, physical examination, including blood...

Countries:United States
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