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Period 1 - Day 1: PF-04965842 administered

Phase 1

Dermatitis, Atopic | Small molecule | Dermatology |Pfizer, Inc.|Last Updated: Jan 30, 2019

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 Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03634345Drug Drug Interaction Study Evaluating the Effect of Fluvoxamine or Fluconazole on PK and Safety of PF-04965842.PHASE1 COMPLETED 24 — — Sep 12, 2018Dec 13, 2018Jan 30, 20191 Belgium
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Study Endpoints
Primary Endpoints
Plasma Cmax for PF 04965842
First 72 hours post PF-04965842 administration in Period 1 and Period 2

Maximum Observed Plasma Concentration (Cmax) for PF 04965842

AUCinf for PF-04965842
First 72 hours post PF-04965842 administration in Period 1 and Period 2

Area Under the Curve From Time Zero to Extrapolated Infinite Time for PF 04965842 (AUCinf)

Secondary Endpoints
Number of subjects with Adverse events (AEs)
Screening up to 28 Days after the Last Dose of PF 04965842
Number of subjects with laboratory tests findings of potential clinical importance
Screening up to 7-14 Days after the Last Dose of PF 04965842 in Period 2
Number of Subjects with clinically significant abnormal Vital Signs
Screening up to 7-14 Days after the Last Dose of PF 04965842 in Period 2
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Study Design & Arms
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
PF-04965842EXPERIMENTALinvestigational drug
Interventions
NameTypeDescription
Period 1 - Day 1: PF-04965842 administeredDRUGPeriod 1: Single administration of 100 mg PF 04965842.
Period 2: Cohort 1: Fluvoxamine & PF-04965842DRUGCohort 1: Period 2: Administration of fluvoxamine from Day 1 to Day 9 and PF-04965842 on Day 8.
Period 2: Cohort 2: Fluconazole & PF-04965842DRUGCohort 2: Period 2: Administration of fluconazole from Day 1 to Day 7 and PF-04965842 on Day 5.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male or female subjects. * Body mass index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight \>50 kg (110 lb). Exclusion Criteria: * Evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologi...

Countries:Belgium
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