Tafenoquine blood levels in healthy Papua New Guinean children
Safety, Pharmacokinetics, and Preliminary Efficacy of Tafenoquine for the Treatment of Vivax Malaria in Papua New Guinean Children
This test measures how a single 10 mg/kg dose of tafenoquine is absorbed and stays in the body in healthy Papua New Guinean children aged 5–12 when given with or without fatty food.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 5 Years to 12 Years |
| Sex | All |
| Sponsor | Curtin University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Madang, Madang Province) |
| Trial ID | NCT07052162 on ClinicalTrials.gov |
What this trial studies
This open-label, randomized pharmacokinetic study will enroll 30 healthy Papua New Guinean children aged 5–12 with normal G6PD activity (>70%) and no current malaria. Participants are randomized 1:1 to receive a single 10 mg/kg dose of tafenoquine given with low-fat biscuits or with a higher-fat chocolate milk, and the first 2–4 days are spent admitted to Alexishafen Health Centre for intensive sampling and monitoring. Venous blood will be taken at eight time points in the first 48 hours and finger-prick samples collected on days 3, 4, 7, 14, 28, 42, and 56, with both plasma and dried blood spots analyzed. Safety monitoring and baseline clinical assessments are performed throughout, and this PK work is the first part of a multi-phase pediatric evaluation in PNG.
Who should consider this trial
Good fit: Healthy children aged 5–12 in Papua New Guinea with confirmed normal G6PD activity (>70%), negative malaria rapid test, no recent antimalarial treatment, no significant illness, and no history of hypersensitivity to primaquine are ideal candidates.
Not a fit: Children with G6PD deficiency (<70% activity), a positive malaria test, recent antimalarial use, significant comorbidities, or known primaquine hypersensitivity are excluded and unlikely to benefit, and participants should not expect direct therapeutic benefit because this is a pharmacokinetic study.
Why it matters
Potential benefit: If successful, the results could define safe and effective tafenoquine dosing in children and guide use to prevent relapses of P. vivax malaria in pediatric populations.
How similar studies have performed: Tafenoquine has demonstrated effective pharmacokinetics and radical cure activity in adults, but pediatric PK and dosing data are limited, so this trial aims to fill that gap.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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
Where this trial is running
Madang, Madang Province
- Alexishafen Health Centre — Madang, Madang Province, Papua New Guinea (Recruiting)
Study contacts
- Principal investigator: Brioni R Moore, PhD — Curtin University
- Study coordinator: Brioni R Moore, PhD
- Email: brioni.moore@curtin.edu.au
- Phone: +61 8 9266 2956
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.