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Lersivirine

Phase 1

Healthy Volunteers | Small molecule | Other |Pfizer, Inc.|Last Updated: May 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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials4
Total Enrollment171
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01230385Safety And Tolerability Of Multiple Dose Lersivirine For 21 Days In Healthy SubjectsPHASE1 COMPLETED 75 — — Oct 1, 2010May 1, 2011May 17, 20112 United States, Belgium
NCT00925535Drug Interaction Study Between Rifabutin And Lersivirine (UK-453,061)PHASE1 COMPLETED 18 — — May 1, 2010Aug 1, 2010Sep 21, 20101 Singapore
NCT01050751Bioavailability Of Lersivirine Single 750 Mg Tablet Versus 3 X 250 Mg TabletsPHASE1 COMPLETED 12 — — Feb 1, 2010Mar 1, 2010Mar 9, 20101 Belgium
NCT00936871The Effect Of Lersivirine (UK-453,061) On Qt Intervals In Healthy SubjectsPHASE1 COMPLETED 66 — — Jan 1, 2010Mar 1, 2010Sep 6, 20101 Belgium
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Study Endpoints
Primary Endpoints
Number of participants with adverse events as a measure of safety and tolerability of multiple doses of lersivirine administered to healthy subjects over 21 days.
21 days
Lersivirine plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h
20 days
Rifabutin and 25-O-desacetyl-rifabutin plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h
20 days
To estimate the bioavailability of 1 x 750 mg lersivirine tablet compared to 3 x 250 mg lersivirine tablets.
7 days
(Part A) To evaluate the safety and toleration of a single dose of lersivirine in healthy male and female subjects.
1 day
(Part B) To demonstrate a lack of effect of lersivirine on QTc relative to time-matched placebo.
3 days
Secondary Endpoints
Lersivirine plasma pharmacokinetic parameter: AUC24, Cmax, C24, and Tmax on Day 7
21 days
Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12 lead ECG and laboratory safety assessments
58 days
To investigate the safety and tolerability of both single oral 750 mg (3 x 250 mg and 1 x 750 mg) dose of lersivirine.
7 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Lersivirine 500 mg QD fasted (wet granulated tablet)EXPERIMENTAL -
Lersivirine 500 mg QD fed (wet granulated tablet)EXPERIMENTAL -
Lersivirine 750 mg QD fasted (wet granulated tablet)EXPERIMENTAL -
Lersivirine 750 mg QD fed (wet granulated tablet)EXPERIMENTAL -
Lersivirine 500 mg QD fasted (dry granulated tablet)ACTIVE_COMPARATOR -
Treatment AACTIVE_COMPARATORLersivirine
Treatment BACTIVE_COMPARATORRifabutin
Treatment CEXPERIMENTALLersivirine and Rifabutin
Lersivirine (new formulation)EXPERIMENTAL -
Lersivirine (old formulation)ACTIVE_COMPARATOR -
Part AEXPERIMENTALLersivirine Tolerability
Part BEXPERIMENTALThorough QTc
Interventions
NameTypeDescription
LersivirineDRUGLersivirine 500 mg QD fasted (wet granulated tablet) for 21 days
RifabutinDRUG300 mg once daily for 10 days
PlaceboDRUGPlacebo single dose
Lersivirine (if necessary)DRUGLersivirine 2100 mg single dose (if necessary)
MoxifloxacinDRUGMoxifloxacin 400 mg single dose
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Healthy male and/or female subjects. * 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...

Countries:United StatesBelgiumSingapore
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