Postpartum 8-aminoquinoline Breast Milk Study

PHASE2/PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

August 31, 2025

Primary Completion Date

August 31, 2026

Study Completion Date

December 31, 2026

Conditions
Drug Pharmacokinetics in Healthy Volunteers
Interventions
DRUG

Daily primaquine (0.5 mg/kg per day) for 14 days given with food food and water

Women will receive daily doses of PQ (0.5 mg/kg per day) for 14 days at a total treatment dose of 7 mg/kg PQ. All doses will be to the nearest full tablet, with food and water to prevent gastrointestinal discomfort, as directly observed treatment. Women vomiting within 30 minutes of administration of any dose will be re-treated.

DRUG

Daily primaquine 1 mg/kg per day for 7 days given with food and water

Women will receive daily doses of PQ (1 mg/kg per day) for 7 days at a total treatment dose of 7 mg/kg PQ. All doses will be to the nearest full tablet, with food and water to prevent gastrointestinal discomfort, as directly observed treatment. Women vomiting within 30 minutes of administration of any dose will be re-treated.

DRUG

Single-dose tafenoquine given with food and water to prevent gastrointestinal discomfort

Women will receive a single dose of 300mg tafenoquine. Treatment will be given with food and water to prevent gastrointestinal discomfort, as directly observed treatment. Women vomiting within 30 minutes of administration of any dose will be re-treated.

Trial Locations (1)

MP511

Alexishafen Health Centre, Madang

All Listed Sponsors
collaborator

Menzies School of Health Research

OTHER

collaborator

Papua New Guinea Institute of Medical Research

OTHER_GOV

lead

Curtin University

OTHER

NCT07060404 - Postpartum 8-aminoquinoline Breast Milk Study | Biotech Hunter | Biotech Hunter