Studying How Tafenoquine Medicine Works and Its Safety in Healthy Papua New Guinean Children Aged 5 to 12 Years

What this Trial Is About

Plasmodium vivax is a widespread malaria species causing many symptomatic cases worldwide, especially affecting children aged 2 to 6 years. Papua New Guinea has intense P. vivax transmission, making it an important place to study treatments for children. This research focuses on understanding the pharmacokinetics of tafenoquine, a potential radical cure drug for eliminating dormant liver-stage parasites that cause relapses in vivax malaria. The study is an open-label, randomized trial involving 30 healthy Papua New Guinean children aged 5 to 12 years with normal G6PD enzyme activity. Participants are divided into two groups one receives a single 10 mgkg dose of tafenoquine with water and a low-fat meal, and the other receives the same dose with chocolate-flavored milk higher fat plus a low-fat meal. Children will stay at the health center for 2 to 4 days for blood sampling and monitoring. Participants will undergo multiple blood collections over 56 days to analyze drug levels and metabolism. Safety assessments including blood counts, liver and kidney function tests, and heart monitoring will be done during follow-up visits. Taste and tolerability will be evaluated shortly after dosing. The study aims to assess tafenoquines pharmacokinetics, safety, and tolerability in children, with follow-up lasting up to 56 days after treatment.

Investigating the Pharmacokinetics of Tafenoquine in Healthy Papua New Guinean Children