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Chloroquine, Tafenoquine

Phase 1

Malaria | Small molecule | Infectious Disease |GSK plc|Last Updated: Jun 19, 2017

Target and mechanism

ModalitySmall molecule

Also known as Chloroquine

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment260

FDA Designations

No designations recorded

Clinical trial landscape

Chloroquine, Tafenoquine · 2 trials · 1 indication

Phase 1 2
NCT01205178G6PD (Glucose-6-phosphate Dehydrogenase) Study to Evaluate Hemolysis Potential of TFQ (Tafenoquine)Malaria
COMPLETED192 Analytics
NCT00871156Tafenoquine/Chloroquine DDI StudyMalaria
COMPLETED68 Analytics
PHASE1COMPLETED
G6PD (Glucose-6-phosphate Dehydrogenase) Study to Evaluate Hemolysis Potential of TFQ (Tafenoquine)
MalariaUnlock trial analytics
PHASE1COMPLETED
Tafenoquine/Chloroquine DDI Study
MalariaUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the safety, tolerability, and hemolytic potential of TQ in G6PD-deficient female healthy volunteers compared with G6PD-normal female healthy volunteers. This will be done by measuring maximum absolute decline in Haemoglobin from baseline
2 years
TQ and Chloroquine (Day 2): AUC(0-tau), Cmax and Tmax
56 days
CQ and TQ (Day 3): AUC(0-tau), AUC(0-inf), Cmax, Tmax and t1/2
56 days
AEs, vital signs, 12-lead ECGs, telemetry, clinical laboratory and ophthalmic assessments
56 days

Secondary Endpoints

Maximum absolute decline in Hgb (or Hct) from baseline for TQ in G6PD-deficient healthy volunteers compared to G6PD-normal healthy volunteers.
1 year
QTcF, QT, QRS, RR and HR as assessed by 12-lead ECG
56 Days
Changes from baseline in QTcF
56 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
TafenoquineACTIVE_COMPARATORTafenoquine, TQ is an 8-aminoquinoline (8-AQ) antimalarial drug being developed for the radical cure of acute P. vivax malaria. Chloroquine will be given for the first 3 days in second and third part of this study to treat Malaria.
ChloroquineACTIVE_COMPARATORDose for first 3 days for Part B \& C of the study
PrimaquineACTIVE_COMPARATORonce daily for first 14 days
Part 1ACTIVE_COMPARATORTafenoquine + Chloroquine vs. Chloroquine alone
Part 2PLACEBO_COMPARATORChloroquine alone, Tafenoquine alone or Chloroquine+Tafenoquine

Interventions

NameTypeDescription
ChloroquineDRUGThe current gold standard for radical cure of P. vivax malaria in many areas of the world is chloroquine (CQ); typically 600 mg day 1, 600 mg day 2, 300 mg day 3 for clearance of the acute parasitemia. After this Tafenoquine will be given and subject will be followed up.
PrimaquineDRUGPrimaquine (PQ) is another 8 aminoquinoline drug available for Malaria treatment
TafenoquineDRUGOnce daily on Day 1 only. For Part B and C of this study Chloroquine will be given to treat Malaria
Chloroquine, TafenoquineDRUGChloroquine and Tafenoquine
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * A subject will be eligible for inclusion in this study only if all of the following criteria apply: * The subject is between 18 and 45 years of age, inclusive * A female is eligible to enter and participate in this study if she is non-pregnant, non-lactating and if she is of: ...

Countries:ThailandUnited States
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Competitive Landscape -Malaria 6 trials

Frequently asked questions about Chloroquine, Tafenoquine

What is Chloroquine used for?

Chloroquine is used for malaria, including Plasmodium vivax malaria. It is being studied in combination with tafenoquine for the prevention of vivax relapse. Chloroquine is a small molecule developed by GSK plc for the infectious disease area.

What does Chloroquine target?

Chloroquine targets the malaria parasite in red blood cells. It interferes with the parasite's ability to break down and detoxify heme, a byproduct of hemoglobin digestion, leading to toxic accumulation and parasite death. This mechanism is effective against blood-stage malaria parasites.

Who makes Chloroquine?

GSK plc (ticker: GSK) is developing Chloroquine. The company is conducting clinical trials to evaluate Chloroquine in combination with tafenoquine for malaria treatment and relapse prevention.

What phase is Chloroquine in?

Chloroquine is in Phase 2 clinical development for malaria. It is an investigational drug in this context, though it has a long history of use. The Phase 2 trial, NCT01376167, is completed and evaluated tafenoquine plus chloroquine for preventing vivax relapse.

What clinical trials is Chloroquine in?

Chloroquine is associated with three completed trials: NCT00871156, a Phase 1 drug-drug interaction study with tafenoquine in healthy volunteers; NCT01205178, a Phase 1 G6PD study evaluating hemolysis potential; and NCT01376167, a Phase 2b/3 study in vivax malaria relapse prevention. Total enrollment across trials was 851 participants.

Is Chloroquine the same as tafenoquine?

No, Chloroquine is not the same as tafenoquine. They are different drugs studied in combination. Chloroquine is a 4-aminoquinoline antimalarial, while tafenoquine is an 8-aminoquinoline. In clinical trials, they are used together to prevent relapse of Plasmodium vivax malaria.