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New treatment option for Pharmacokinetics of Tafenoquine
Official title Investigating the Pharmacokinetics of Tafenoquine in Healthy Papua New Guinean Children
ClinicalTrials.gov ID: NCT07052162
What this study is testing
What is Single dose tafenoquine (10 mg/kg) given with water?
Single dose tafenoquine (10 mg/kg) given with water is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for pharmacokinetics of tafenoquine.
Also referred to as TQ, Tafenoquine succinate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Plasmodium vivax is the most geographically widespread malaria species and the second largest contributor to symptomatic malaria worldwide. It accounts for half of all malaria cases outside Africa, with an estimated 14.3 million clinical vivax malaria cases reported annually, contributing to an annual cost of US$359 million.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 12. Healthy volunteers may be eligible.
You may be able to join if
- have a normal glucose-6-phosphate-dehydrogenase (G6PD) activity (\>70% enzyme activity) as confirmed by quantitative SD Biosensor
- are Rapid Diagnostic Test negative for malaria
- have not received treatment with any antimalarial in the previous 4-weeks
- have no signs or symptoms of significant morbidity
- have no history of hypersensitivity to primaquine
You likely can't join if
- have G6PD activity \<70%
- test positive for malaria by rapid diagnostic test
- have receive treatment with an antimalarial in the previous 4-weeks
- have signs or symptoms of significant morbidities
- have a history of primaquine related hypersensitivity
- cannot, or are not willing, to attend all scheduled follow-up visits
See the full eligibility criteria
- have a normal glucose-6-phosphate-dehydrogenase (G6PD) activity (\>70% enzyme activity) as confirmed by quantitative SD Biosensor
- are Rapid Diagnostic Test negative for malaria
- have not received treatment with any antimalarial in the previous 4-weeks
- have no signs or symptoms of significant morbidity
- have no history of hypersensitivity to primaquine
- are able to attend all scheduled follow-up visits
- have G6PD activity \<70%
- test positive for malaria by rapid diagnostic test
- have receive treatment with an antimalarial in the previous 4-weeks
- have signs or symptoms of significant morbidities
- have a history of primaquine related hypersensitivity
- cannot, or are not willing, to attend all scheduled follow-up visits
The study team makes the final eligibility decision.
Where it's taking place
- Madang, Madang Province, Papua New Guinea
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 12 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madang, Madang Province, Papua New Guinea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.