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Atovaquone/proguanil

Phase 1

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

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

Clinical trial landscape

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
Malaria
NCT0185883130
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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 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 6 trials

CompanyTickerTrialsLead PhaseDrugs
GSK plc Sponsored ADRGSK3PHASE3Tafenoquine, Primaquine, Chloroquine
Novartis AG Sponsored ADRNVS1PHASE2INE963, KAE609, KLU156
60 Degrees Pharmaceuticals, Inc.SXTP1PHASE2Tafenoquine
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Frequently asked questions about Atovaquone/proguanil

What is atovaquone/proguanil used for?

Atovaquone/proguanil is a small molecule combination drug being studied for the treatment of malaria. It is currently in Phase 1 clinical development as an investigational therapy for this infectious disease.

Who makes atovaquone/proguanil?

Atovaquone/proguanil is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK.

What phase is atovaquone/proguanil in?

Atovaquone/proguanil is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities for the treatment of malaria.

What clinical trials is atovaquone/proguanil in?

Atovaquone/proguanil has one completed clinical trial, NCT01858831, which was a single oral dose study of atovaquone/proguanil hydrochloride combination tablets and atovaquone suspension. The trial enrolled 30 healthy male volunteers in Japan.

Is atovaquone/proguanil the same as atovaquone/proguanil hydrochloride?

Atovaquone/proguanil is the combination drug, and the clinical trial NCT01858831 studied atovaquone/proguanil hydrochloride combination tablets. The hydrochloride form is a salt version of the combination used in the tablet formulation.