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Atovaquone/proguanil

Phase 2

Malaria | Small molecule | Infectious Disease |GSK plc|Trials Updated: Mar 22, 2017

Atovaquone/proguanil development status

Highest phase Phase 2 run by Pfizer (NCT00084227)
Phase scored for GSKPhase 1
Registered trials 2 across 2 sponsors since Jun 2004

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Atovaquone/proguanil clinical trials

Atovaquone/proguanil · 1 trial · 1 indication

Phase 1 1
NCT01858831Single Oral Dose Study of Atovaquone/Proguanil Hydrochloride Combination Tablets and Atovaquone SuspensionMalaria
COMPLETED30 Analytics
PHASE1COMPLETED
Single Oral Dose Study of Atovaquone/Proguanil Hydrochloride Combination Tablets and Atovaquone Suspension
MalariaUnlock trial analytics

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 to 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 19 trials

Frequently asked questions about Atovaquone/proguanil

What is atovaquone/proguanil used for?

Atovaquone/proguanil is used for malaria. It is an antimalarial small molecule combination developed by GSK plc, which trades under the ticker GSK. The program is in Phase 1 clinical development, and the malaria indication places it in the infectious disease therapeutic area.

Who makes atovaquone/proguanil?

Atovaquone/proguanil is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor behind the clinical program for this antimalarial combination, including the Phase 1 study conducted in Japan.

What phase is atovaquone/proguanil in?

Atovaquone/proguanil is in Phase 1 clinical development. It is an investigational antimalarial combination and is not described as approved. The program has one completed Phase 1 trial, with no active trials currently listed.

What clinical trials is atovaquone/proguanil in?

Atovaquone/proguanil has been studied in one completed Phase 1 trial, NCT01858831, titled Single Oral Dose Study of Atovaquone/Proguanil Hydrochloride Combination Tablets and Atovaquone Suspension. That trial enrolled 30 healthy male volunteers aged 20 years and older in Japan and was active controlled.