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Tasocitinib plus Ketoconazole

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Feb 17, 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
RandomizedCONTROLLEDBiomarker
Total Trials3
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01202240Effect Of Ketoconazole On The Pharmacokinetics Of Tasocitinib (CP-690,550) In Healthy VolunteersPHASE1 COMPLETED 12Sep 1, 2010Sep 1, 2010Feb 17, 20111 Belgium
NCT01204112Estimate The Effect Of Repeat-Dose Rifampin On The Pharmacokinetics Of CP-690,550 In Healthy VolunteersPHASE1 COMPLETED 12Sep 1, 2010Oct 1, 2010Oct 22, 20101 United States
NCT01143805A Study To Estimate The Amount Of CP-690,550 (Study Drug) That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of CP-690,550 In Tablet FormPHASE1 COMPLETED 12Jul 1, 2010Aug 1, 2010Aug 10, 20101 Singapore
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Study Endpoints
Primary Endpoints
AUCinf of tasocitinib (CP-690,550)
5 days
Cmax of tasocitinib (CP-690,550)
9 days
AUCinf of tasocitinib (CP 690,550)
PK blood samples out to 12 hours post dose
Secondary Endpoints
AUClast, Cmax, and Tmax of tasocitinib (CP-690,550)
5 days
Safety: laboratory tests, AE reporting and vital signs
5 days
AUClast, Tmax, t1/2 of tasocitinib (CP-690,550)
9 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Tasocitinib (CP-690,550) plus KetoconazoleEXPERIMENTAL -
Tasocitinib (CP-690,550) plus RifampinEXPERIMENTAL -
Treatment A: Tasocitinib 10 mg oral tabletEXPERIMENTAL -
Treatment B: Tasocitinib 10 mg IV InfusionEXPERIMENTAL -
Interventions
NameTypeDescription
Tasocitinib (CP-690,55) plus KetoconazoleDRUGPeriod 1, Day 1: tasocitinib (CP-690,550) as a single oral 10 mg dose given as two 5 mg tablets Period 2, Days 1-2: ketoconazole as a daily single oral 400 mg (dose given as two 200 mg tablets Period 2, Day 3: ketoconazole as a single oral 400 mg dose given as two 200 mg tablets PLUS tasocitinib (CP-690,550) as a single oral 10 mg oral dose given as two 5 mg tablets Period 2, Day 4: No treatment (discharge)
Tasocitinib (CP-690,550) plus RifampinDRUGPeriod 1, Day 1: Tasocitinib (CP-690,550) 30 mg (single oral dose) as six 5 mg tablets Period 2, Day 1-7: Rifampin 600 mg (single oral dose) q24h Period 2, Day 8: Tasocitinib (CP-690,550) 30 mg (single oral dose) as six 5 mg tablets Period 2, Day 9: No treatment (discharge)
Tasocitinib 10 mg oral tabletDRUGTreatment A: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of an oral tablet
Tasocitinib 10 mg IV InfusionDRUGTreatment B: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of a 30 minute intravenous infusion
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female (non-childbearing potential) subjects between the ages of 18 and 55 years Exclusion Criteria: * Clinically significant disease * Recent history of serious infection

Countries:BelgiumUnited StatesSingapore
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