Recent Updates
Recently added Catalysts

PF-04991532 alone

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Sep 7, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01370343Single Dose Study Of The Effect Of Cyclosporine On The Pharmacokinetics Of PF-04991532 In Health VolunteersPHASE1 COMPLETED 12Jul 1, 2011Jul 1, 2011Sep 7, 20111 Belgium
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Area under the plasma concentration versus time profile (AUC)
predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hrs postdose
Max observed plasma concentration (Cmax)
predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hrs postdose
Secondary Endpoints
Time of Cmax (Tmax)
predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hrs postdose
Terminal elimination half-life (t1/2)
predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hrs postdose
Total amount of unchanged drug excreted in the urine over 24 hours (Ae24)
0-8, and 8-24hr postdose
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
PF-04991532 aloneEXPERIMENTAL -
PF-04991532 + cyclosporineEXPERIMENTAL -
Interventions
NameTypeDescription
PF-04991532 aloneDRUGa single dose of 150 mg PF-04991532, fasted
PF-04991532 + cyclosporineDRUGa single dose of 150 mg PF-04991532 + a single dose of 600 mg cyclosporine, fasted
Unlock Study Design Details
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, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse r...

Countries:Belgium
Unlock Eligibility Criteria