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darunavir/ritonavir

Phase 1

Healthy Subjects | Small molecule | Other |GSK plc|Last Updated: Nov 3, 2010

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00920088Drug Interaction Study of Darunavir/Ritonavir and Lopinavir/Ritonavir on GSK2248761 PK and CYP450 Probe DrugsPHASE1 COMPLETED 24Jun 1, 2009Nov 1, 2009Nov 3, 20101 United States
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Study Endpoints
Primary Endpoints
PK parameters
35 days
Secondary Endpoints
12-lead ECGs
35 days
clinical laboratory assessments
35 days
vital signs
35 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTALGSK2248761 with LPV/RTV arm and probes
Cohort 2EXPERIMENTALGSK2248761 with DRV/RTV
Interventions
NameTypeDescription
darunavir/ritonavirDRUGDRV/RTV 600/100mg
lopinavir/ritonavirDRUGLPV/RTV 400/100mg
MidazolamDRUGMidazolam 3mg
DextromethorphanDRUGDextromethorphan 30mg
FlurbiprofenDRUGFlurbiprofen 50mg
GSK2248761DRUGNNRTI under investigation
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. * Male or female between 18 and 50 years of age inclusive, at the time of signing the infor...

Countries:United States
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