A Phase 4 interventional study of Single dose tafenoquine (10 mg/kg) given with water and Single dose tafenoquine (10 mg/kg) given with fat in Pharmacokinetics of Tafenoquine, sponsored by Curtin University. Recruiting at 1 site in Papua New Guinea. Open to participants aged 5 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by Curtin University · Phase 4, Interventional, and Treatment
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. Children are most vulnerable to infection, with P. vivax prevalence peaking between 2 to 6 years of age. In Papua New Guinea (PNG), there are >1.5 million suspected P. vivax cases annually, and while P. falciparum infections are the most prevalent, P. vivax transmission is the most intense in the world. P. vivax in PNG provides a unique epidemiological setting in which to assess innovative treatments in children.
The complex biology of P. vivax represents a challenge for malaria control and chemotherapy, especially dormant liver-stage parasites (hypnozoites) which can reactivate (relapse) and cause disease at a time remote from the primary infection. Hypnozoite relapse is the primary cause of vivax malaria in endemic regions and is resistant to most antimalarial drugs. Identifying effective treatments for radical cure, the complete elimination of parasites (both blood- and liver-stage), is therefore a priority. The World Health Organization (WHO) recommends a 14-day radical cure regimen for uncomplicated vivax malaria; comprised of blood stage treatment (chloroquine or artemisinin combination therapy (ACT)) and 14 days of the 8-aminoquinoline drug primaquine (PQ; 0.25-0.5 mg/kg/day) for liver-stage cure. More recently, the 8-aminoquinoline tafenoquine has garnered interest as an alternative radical cure agent to primaquine. However, there is limited data on the pharmacokinetics, tolerability and radical cure efficacy of tafenoquine in children.
The overall aim of the study is to characterise the pharmacokinetic profile of tafenoquine (and primary metabolite) in Papua New Guinean children.
This is an open-label study to evaluate the pharmacokinetic disposition of tafenoquine, with and without coadministration of fat, in healthy Papua New Guinean children. This study represents the first part of a multi-phase evaluation of tafenoquine in PNG children (preliminary efficacy study registered separately).
In this study, healthy PNG children aged 5-12 year will be eligible for inclusion into the study providing they have normal G6PD activity (>70% enzyme activity) and no history of previous hypersensitivity to 8-aminoquinoline drugs. All participants will be admitted to the Alexishafen Health Centre for the first 2-4 days of the study, to facilitate blood sampling and clinical monitoring.
After admission, baseline demographic and medical history will be taken, and the participants will undergo a full clinical assessment to establish baseline safety indices. The 30 participants will then be randomized 1:1 to receive either:
Group A: single dose tafenoquine (10 mg/kg) with water (and cracker biscuits (2% fat), to mitigate gastrointestinal complaints, or Group B: single dose tafenoquine (10 mg/kg) with 250mL of chocolate flavoured mild (9% fat; and cracker biscuits (2% fat)).
For pharmacokinetic analysis, venous blood samples will be collected (via indwelling cannula) at 8 time points within the first 48-hours of drug administration, with further finger prick samples collected on days 3, 4, 7, 14, 28, 42 and 56. Both dried blood spot and plasma samples will be collected at all time points for pharmacokinetic analyses.
Standardised review, including adverse-effect questionnaires, and clinical monitoring (haemoglobin, methaemoglobin, reticulocyte counts, malaria blood films) will be conducted at all daily follow-up time points (Days 0, 1, 2, 3, 4, 7, 14, 28, 42, and 56). Safety testing (hepatorenal function tests (ALT, total bilirubin, creatinine), haemoglobin, urine dipstick analysis and electrocardiogram trace, will be taken at 4, 12, 24 hours and on Days 3, 7 and 28. A standardized clinical taste evaluation survey will be conducted (child or parent response, age dependent) 30 minutes of dosing, which will be repeated on Day 1.
Secondary objectives:
The investigators hypothesise that:
123 studies on the registry are indexed under Malaria, Vivax; 19 are open to participants now.
This study's planned enrollment of 30 is below the median of 150 across 103 interventional studies indexed under Malaria, Vivax.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single-dose tafenoquine as 10 mg/kg taken with water and a low-fat meal (3 plain cracker biscuits; 2% fat)
Drug: Single dose tafenoquine (10 mg/kg) given with water
Single-dose tafenoquine as 10mg/kg taken with 250 mL chocolate flavoured milk (9% fat) and a low-fat meal (3 plain cracker biscuits; 2% fat).
Drug: Single dose tafenoquine (10 mg/kg) given with fat
Drug page: Tafenoquine
Participants will receive single-dose TQ as 10 mg/kg taken with water and a low-fat meal (3 plain cracker biscuits; 2% fat). Food (low-fat meal) is taken with both regimens to attenuate any gastrointestinal adverse effects that are related to taking TQ on an empty stomach. Combinations of full or half-tablets will be swallowed whole or crushed lightly (tablets) or dissolved in boiled water (if dispersible tablets are available), as directly observed treatment. Children vomiting within the first 30 minutes of treatment will be withdrawn
Also known as: TQ, Tafenoquine succinate, Kodatef
Drug page: Tafenoquine
Single-dose TQ as 10 mg/kg taken with 250 mL chocolate flavoured milk (9% fat) and a low-fat meal (3 plain cracker biscuits). Food (low-fat meal) is taken with both regimens to attenuate any gastrointestinal adverse effects that are related to taking TQ on an empty stomach. Combinations of full or half-tablets will be swallowed whole or crushed lightly (tablets) or dissolved in boiled water (if dispersible tablets are available), as directly observed treatment. Children vomiting within the first 30 minutes of treatment will be withdrawn
Also known as: TQ, Tafenoquine succinate, Kodatef
Pharmacokinetic: Distribution half-life
Pharmacokinetic parameters of tafenoquine and 5,6-orthoquinone tafenoquine, will be ascertained using a nonlinear mixed-effects modelling approach (NONMEM), based on drug concentrations determined from venous blood samples collected at baseline (Day 0), 2, 4, 8, 12, 18, 24, 36 and 48 hours from a sampling cannula with capillary finger-prick samples at Days 3, 4, 7, 14, 28, 42 and 56.
Time frame: 56-days after drug administration
Pharmacokinetic: Terminal elimination half-life
Time frame: 56-days after drug administration
Pharmacokinetic: Absorption half-life
Time frame: 56-days after drug administration
Pharmacokinetics: Clearance
Time frame: 56-days after drug administration
Pharmacokinetics: Volume of distribution
Time frame: 56-days after drug administration
Pharmacokinetics: Maximal concentration
Time frame: 56-days after drug administration
Pharmacokinetics: Area under concentration-time curve
Time frame: 56-days after drug administration
Safety: Change in haemoglobin over 28 days
After admission, baseline demographic details (age, weight, height) and a detailed clinical history will be taken. All participants will then undergo a full clinical assessment, documenting axillary temperature, heart and respiration rate, and methaemoglobin level (pulse oximetry; Rad57 pulse oximeter with SpMet% function). A blood sample will be drawn prior to drug administration via the cannula for baseline laboratory tests (safety analysis) and genotyping, including: i) Haemoglobin and blood glucose ii) Dipstick urinalysis iii) Resting 12-lead electrocardiogram for rate-corrected QT interval iv) 250 μL blood sample for CYP2D6 genotyping v) Reticulocyte count vi) Hepatorenal function Safety testing, including collection of a 100 μL blood sample for hepatorenal function tests (ALT, total bilirubin and creatinine), haemoglobin, methaemoglobin, urine dipstick analysis (blood, protein and glucose), and an electrocardiogram trace, will be taken at 4, 12, 24 hrs, and on Days 3, 7 and 28.
Time frame: 28-days from drug administration
Safety: Change in methaemoglobin over 28 days
Time frame: 28-days from drug administration
Safety: Change in hepatorenal function over 7 days
Time frame: 7-days from drug administration
Safety: Change in rate corrected QTc over 28 days
Time frame: 28-days from drug administration
Tolerability: Taste and tolerability assessment
A standardized clinical taste evaluation/tolerability survey will be conducted (child or parent response, dependent on age) 30 minutes after TQ dosing, which will be repeated on Day 1. This survey will investigate the participant's feelings towards the dosing experience (taste, tablet size, ease of swallowing) and any treatment related side effects (focussing on known complications including nausea, gastrointestinal disruption, vomiting).
Time frame: 1-day following drug administration
Safety and tolerability: Number of participants with treatment-related adverse events as assessed by standardised questionnaire
Symptom questionnaires (used across all research conducted at this site) will be conducted at each follow-up time point from baseline (Day-0) until end of study (day 56). The questionnaire will determine the frequency, duration and rating (mild, moderate, severe) of each adverse event experienced, from the perspective of the participant/caregiver and clinic staff.
Time frame: 56-days after drug administration
Plan to share: No — Data maybe shared upon contact with the principal investigators and approval by the PNG Institute of Medical Research. This process will be conducted on a case by case basis, as per agreements between collaborative partners.
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Studies of the drug tested here: Tafenoquine
Curtin University