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GSK706769 & KALETRA

Phase 1

Infection, Human Immunodeficiency Virus | Small molecule | Other |GSK plc|Last Updated: Jul 21, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment17
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00723775GSK706769/KALETRA Drug-drug Interaction StudyPHASE1 COMPLETED 17Jul 24, 2008Nov 8, 2008Jul 21, 20171 United States
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Study Endpoints
Primary Endpoints
GSK706769 PK
Part 1: 4 days; Part 2; 25 days
Secondary Endpoints
GSK706769 safety parameters, including adverse events, clinical laboratory, ECG, and vital signs assessments.
Part 1: 4 days; Part 2; 25 days
Plasma GSK706769 AUC(0-∞), AUC(0-t), and Cmax following a single dose of GSK706769 50mg and following combined administration of a single dose of GSK706769 50mg with a single dose of LPV 400mg/RTV 100mg.
Part 1: 4 days; Part 2; 25 days
Plasma metabolite GSK1996847 AUC(0-∞), AUC(0-t), and Cmax following a single dose of GSK706769 50mg and following combined administration of a single dose of GSK706769 50mg with a single dose of LPV 400mg/RTV 100mg.
Part 1: 4 days; Part 2; 25 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1OTHERGSK706769 new vs. current formulation; GSK706769 alone vs. GSK706769 plus Kaletra
Part 2OTHERGSK706769 alone for 10 days; GSK706769 + Kaletra for 14 days
Interventions
NameTypeDescription
GSK706769 & KALETRADRUGGSK706769 alone and GSK706769 + Kaletra
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the populati...

Countries:United States
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