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PF 06835919

Phase 1

Healthy Volunteer | Small molecule | Other |Pfizer, Inc.|Last Updated: Jul 16, 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
RandomizedCONTROLLED
Total Trials1
Total Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03916406THE EFFECT OF MULTIPLE DOSES OF PF-06835919 ON THE PHARMACOKINETICS OF A SINGLE ORAL MIDAZOLAM DOSE IN HEALTHY PARTICIPANTSPHASE1 COMPLETED 10Apr 18, 2019Jun 25, 2019Jul 16, 20191 Belgium
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Study Endpoints
Primary Endpoints
AUCinf of midazolam following a single oral dose
Baseline up to 51 days

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

Secondary Endpoints
AUClast of midazolam following a single oral dose.
Baseline up to 51 days
Cmax of midazolam following a single oral dose.
Baseline up to 51 days
Incidence of Adverse Events in participants
Screening up to 79 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
Sequence 1EXPERIMENTALmidazolam alone followed by combination of PF 06835919 and midazolam
Sequence 2EXPERIMENTALPF 06835919 in combination with midazolam followed by midazolam alone
Interventions
NameTypeDescription
PF 06835919DRUG300 mg
MidazolamDRUG7.5 mg
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male and female participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiovascular tests. * Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb). Exclusion Cri...

Countries:Belgium
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