Investigating the Pharmacokinetics of Tafenoquine in Healthy Papua New Guinean Children

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

July 31, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Pharmacokinetics of Tafenoquine
Interventions
DRUG

Single dose tafenoquine (10 mg/kg) given with water

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 Children vomiting within the first 30 minutes of treatment will be withdrawn

DRUG

Single dose tafenoquine (10 mg/kg) given with fat

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 Children vomiting within the first 30 minutes of treatment will be withdrawn

Trial Locations (1)

MP511

Alexishafen Health Centre, Madang

All Listed Sponsors
collaborator

Papua New Guinea Institute of Medical Research

OTHER_GOV

collaborator

The University of Western Australia

OTHER

lead

Curtin University

OTHER