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Abacavir/Lamivudine

Phase 1

Healthy Volunteers | Small molecule | Other |Pfizer, Inc.|Last Updated: Feb 4, 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
ACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01220232Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy SubjectsPHASE1 COMPLETED 14 — — Nov 1, 2010Jan 1, 2011Feb 4, 20111 United States
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Study Endpoints
Primary Endpoints
To estimate the effect of steady state lersivirine 750 mg on the steady state pharmacokinetics of abacavir/lamivudine.
17 days
Secondary Endpoints
To investigate the safety and tolerability of lersivirine when co-administered with abacavir/lamivudine.
17 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Abacavir/LamivudineACTIVE_COMPARATOR -
Lersivirine + Abacavir/LamivudineEXPERIMENTAL -
Interventions
NameTypeDescription
Abacavir/LamivudineDRUGAbacavir/Lamivudine 600/300 mg QD for 5 days
LersivirineDRUGLersivirine 750 mg QD for 10 days
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2. * Total body weight \>50 kg (110 lbs). Exclusion Criteria: * History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL...

Countries:United States
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