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Lamivudine

Phase 1

Hepatitis B, Chronic | Small molecule | Infectious Disease |GSK plc|Last Updated: Aug 4, 2017

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 Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01353742Lamivudine and Adefovir Dipivoxil Fixed Dose CombinationPHASE1 COMPLETED 40 — — Feb 21, 2011Apr 12, 2011Aug 4, 20171 Hong Kong
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Study Endpoints
Primary Endpoints
AUC of lamivudine
48 hours
Cmax of lamivudine
48 hours
AUC of adefovir dipivoxil
48 hours
Cmax of adefovir dipivoxil
48 hours
Secondary Endpoints
PK parameters: t1/2 of lamivudine
48 hours
Tolerability will be assessed by clinical data from Adverse Event reporting, nurse/physician observations, vital signs, ECGs, and clinical laboratory.
48 hours
PK parameters: Tmax of lamivudine
48 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Lamivudine and Adefovir dipivoxilACTIVE_COMPARATOROne 100mg Lamivudine tablet and One 10mg Adefovir dipivoxil tablet
Fixed dose combinationEXPERIMENTALOne capsule (100mg lamivudine and 10mg adefovir dipivoxil)
Interventions
NameTypeDescription
LamivudineDRUG100mg tablet
Adefovir dipivoxilDRUG10mg tablet
Fixed dose combination (Lamivudine and Adefovir dipivoxil)DRUG100mg/10mg capsule
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy as determined by a responsible physician. * Male 18 and 55 years of age. * Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods. * Body weight \>50 kg (110 lbs) and body mass index (BMI) between 19.0 and 25.0....

Countries:Hong Kong
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