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GSK369796

Phase 1

Malaria | Small molecule | Infectious Disease |GSK plc|Last Updated: Sep 13, 2018

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 Enrollment41
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00675064Single-Blind, Placebo-Controlled, Randomized Study Testing Single Ascending Doses Of GSK369796 In Healthy SubjectsPHASE1 COMPLETED 41May 2, 2008Oct 12, 2008Sep 13, 20181 United Kingdom
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Study Endpoints
Primary Endpoints
Safety and tolerability
From Day 1 to follow-up visit
Secondary Endpoints
Pharmacokinetics
Day 1 to Day 4
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
Anti-malarial experimental drugEXPERIMENTALAfter randomization subjects will receive either 5, 25, 100, 250, 500, 1000, 2000 and 3000 mg of GSK3697969 orally . GSK3697969 will be available as 5, 25 and 250 mg capsules.
Matching placeboACTIVE_COMPARATORAfter randomization subjects will receive matching placebo of GSK3697969.
Interventions
NameTypeDescription
GSK369796DRUGAnti-malarial
PlaceboDRUGPlacebo matching GSK369796
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Eligibility Criteria
Age Range18 Years — 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy adults between the ages of 18 to 40, inclusive. * Female subjects must be of non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or bilateral oophrectomy or postmenopausal defined as 6 months of spontan...

Countries:United Kingdom
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Competitive Landscape -Malaria 8 trials