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Atovaquone/proguanil

Phase 1

Malaria | Small molecule | Infectious Disease |GSK plc|Last Updated: Mar 22, 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 Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01858831Single Oral Dose Study of Atovaquone/Proguanil Hydrochloride Combination Tablets and Atovaquone SuspensionPHASE1 COMPLETED 30Apr 1, 2012May 1, 2012Mar 22, 20171 Japan
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Study Endpoints
Primary Endpoints
plasma atovaquone concentration
pre, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 120, 168, 216, 336 post dose
plasma proguanil concentration
pre, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 120, 168, 216, 336 post dose
plasma cycloguanil concentration
pre, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 120, 168, 216, 336 post dose
Secondary Endpoints
Number of participants with adverse events
up to 336h post dose
Change in Systolic Blood Pressure
at pre-dose, 4, 24, 72, 168 and 336 h post-dose
Change in ECG findings
at pre-dose, 4, 72, 168 and 336 h post-dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
Atovaquone/proguanil HCLEXPERIMENTALAtovaquone/proguanil HCL
Atovaquone 750 mgACTIVE_COMPARATORAtovaquone 750 mg
Atovaquone 1500 mgACTIVE_COMPARATORAtovaquone 1500 mg
Interventions
NameTypeDescription
Atovaquone/proguanil HCLDRUGAtovaquone/proguanil HCL
AtovaquoneDRUGAtovaquone
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Eligibility Criteria
Age Range20 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy as defined as being free from clinically significant illness or disease as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, vital sign, laboratory tests and ECG. * Japanese healthy mal...

Countries:Japan
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Competitive Landscape -Malaria 8 trials