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Lersivirine Immediate-Release

Phase 1

Healthy Volunteer | Small molecule | Other |Pfizer, Inc.|Last Updated: Sep 19, 2012

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
UNCONTROLLED
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01603485Study to Estimate the Pharmacokinetics, Bioavailability and Effect of Food on Single Dose Modified-release Lersivirine 500 mg in Healthy SubjectsPHASE1 COMPLETED 16 — — Jun 1, 2012Aug 1, 2012Sep 19, 20121 Belgium
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Study Endpoints
Primary Endpoints
Lersivirine Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose
Lersivirine Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose
Lersivirine Maximum Observed Plasma Concentration (Cmax)
T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose
Secondary Endpoints
Lersivirine Plasma Decay Half-Life (t1/2)
T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose
Lersivirine Time to Reach Maximum Observed Plasma Concentration (Tmax)
T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose
Lersivirine Observed Plasma Concentration at time 24hr (C24)
T = 24 hours post dose
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LersivirineEXPERIMENTAL -
Interventions
NameTypeDescription
Lersivirine Immediate-Release (fasted)DRUGSingle 500 mg dose of Lersivirine Immediate-Release Tablets (2 x 250 mg)
Lersivirine Modified-Release #1 (fasted)DRUGSingle 500 mg dose of Lersivirine Modified-Release Tablet #1
Lersivirine Modified-Release #2 (fasted)DRUGSingle 500 mg dose of Lersivirine Modified-Release Tablet #2
Lersivirine Modified-Release #3 (fasted)DRUGSingle 500 mg dose of Lersivirine Modified-Release Tablet #3
Lersivirine Modified-Release (fed)DRUGSingle 500 mg dose of Lersivirine Modified-Release Tablet dosed with food.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria: * History of regular alcohol consump...

Countries:Belgium
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