Drug Pharmacokinetics in Healthy VolunteersPhase 2/3NCT07060404
Postpartum 8-aminoquinoline Breast Milk Study
A Phase 2/3 study testing Daily primaquine (0.5 mg/kg per day) for 14 days given with food food and water, Daily primaquine 1 mg/kg per day for 7 days given with food and water and Single-dose tafenoquine given with food and water to prevent gastrointestinal discomfort in people with Drug Pharmacokinetics in Healthy Volunteers, run by Curtin University at 1 site in Papua New Guinea.
Trial summary
In Papua New Guinea, administration of primaquine (PQ) or tafenoquine (TQ) to breastfeeding mothers is contraindicated during the first six months postpartum, when infants are recommended to be exclusively breastfed, because of a lack of comprehensive pharmacokinetic data on PQ/TQ neonatal and infant exposure via… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Drug Pharmacokinetics in Healthy Volunteers
- What is being tested?
- Daily primaquine (0.5 mg/kg per day) for 14 days given with food food and water, Daily primaquine 1 mg/kg per day for 7 days given with food and water and Single-dose tafenoquine given with food and water to prevent gastrointestinal discomfort
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePapua New Guinea
- Study dates
- Apr 2026to May 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- Both mother and infant have G6PD activity >70% (normal activity; SD Biosensor)
- They have no significant co-morbidity
- Delivered a live singleton baby within past 48-hours
- Rapid diagnostic test negative for malaria
- No history of hypersensitivity to 8-aminoquinoline drugs
Show all 9Show fewer
- Plan to exclusively breastfeed for at least two months
- History of vivax malaria (as per health book)
- They can attend follow-up assessments for the duration of the study
Who cannot join
- Either mother/infant have G6PD activity <70% (SD Biosensor)
- Either mother/infant have significant co-morbidity
- Mother did not deliver a live singleton within past 48-hours
- Mother/infant are rapid diagnostic test positive for malaria
- Mother has a history of hypersensitivity to 8-aminoquinoline drugs
- Mother does not plan to exclusively breastfeed for at least two months
- Mother does not have a history of vivax malaria (as per health book)
- Cannot or are not willing to attend follow-up assessments for the duration of the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Papua New Guinea1 site
Alexishafen Health Centre
Madang, Madang Province, MP511
Paula Tesine, Dr, +675 434 02058
About this study
Official title: Pharmacokinetics of Primaquine and Tafenoquine in Lactating Women - Towards Equitable Radical Cure of Vivax Malaria
In Papua New Guinea, administration of primaquine (PQ) or tafenoquine (TQ) to breastfeeding mothers is contraindicated during the first six months postpartum, when infants are recommended to be exclusively breastfed, because of a lack of comprehensive pharmacokinetic data on PQ/TQ neonatal and infant exposure via breast milk. The therapeutic restriction of PQ/TQ use in lactating women during the first six months postpartum effectively translates into ~10% of females being excluded from radical cure in endemic areas at any time. This is because many at risk women live in remote areas, are frequently lost to follow-up, or may have conceived again before they reattend. As a result, radical cure is rarely achieved and women are exposed to recurrent infections and cumulative risk of anaemia. Relapses may occur for years, placing subsequent pregnancies at risk and perpetuating intergenerational failure of fetal growth. They also contribute to malaria transmission, thus household and community exposure to vivax malaria.
The goal of the present study is to determine how much PQ/TQ is transferred to a suckling baby, if a mother receives a treatment course of PQ/TQ at time of delivery. We also want to confirm that this treatment is safe and has no major side effects for babies in Papua New Guinea.
Read more
The study Interventions areas follows: Group 1 - Participants receive PNG standard of care; PQ given 6-months postpartum; Group 2 - Participants receive a 14-day treatment regimen of PQ, at the standard dose prescribed in PNG for vivax radical cure (0.5 mg/kg/day for 14 days); Group 3 - Participants receive an accelerated high-dose 7-day treatment regimen of PQ, as per current WHO recommendations (1.0 mg/kg/day for 7 days); Group 4 - Participants receive a single dose of 300mg tafenoquine.
All participants will be monitored for a total duration of 6 months, with the safety, tolerability, pharmacokinetics and preliminary relapse efficacy of PQ/TQ evaluated at standardised time points over this period (Day 0, 1, 3, 6, 8, 15, 20, 28, and Month 2, 3, 4, 5 and 6). At each of these time points, participants will be asked to describe any symptoms they may be experiencing, participate in a medical examination, and provide a blood and breast milk sample for drug analysis and safety (biochemistry and haematology testing). The investigators will also collect a small blood sample (heel prick) from the infant to measure drug concentrations and safety testing.
Read the detailed description
Global malaria eradication requires universal and equitable access to effective antimalarial treatment. More than 2.5 billion people are at risk of infection with Plasmodium vivax. Unlike falciparum malaria, P. vivax forms dormant liver-stage parasites (hypnozoites) that can reactivate (relapse) causing recurrent febrile illness after the initial infection. Women are at increased risk of vivax malaria during pregnancy and postpartum, when they are at higher risk of P. vivax infections than P. falciparum malaria. Over 80% of these infections are relapses, rather than new infections but pregnant and lactating women cannot be treated with the available anti-relapse drugs. This is because the 8-aminoquinolones, primaquine (PQ) and tafenoquine (TQ), can cause potentially life-threatening haemolysis in glucose-6-phosphate dehydrogenase (G6PD)-deficient babies, and there is concern that the drugs are transferred in breast milk. If anti-relapse treatment could be given immediately on delivery and before discharge, it would dramatically reduce the risk of vivax relapses which currently affect ~10% of women in countries like Papua New Guinea (PNG).
This study aims to accelerate maternal access to PQ/TQ by confirming minimal transfer of PQ or TQ not only in mature breast milk (>2 weeks postpartum; current data available from a pharmacokinetic (PK) study in Thailand), but also in colostrum and transitional breast milk in the first two weeks after birth. Generating PK data for TQ is also critical. Maternal treatment could then be initiated before hospital discharge to prevent postpartum relapses and maximise benefit for health outcomes and malaria control.
This open-label study has the following objectives and hypothesis:
Primary Objective: To determine the transfer of primaquine (and primary metabolite carboxyprimaquine) and tafenoquine in breast milk (colostrum and transitional milk) and determine associated relative infant exposure.
Secondary objectives include; i) To compare haematological and hepatorenal indices in exposed and unexposed mother-infant pairs as a measure of safety, and ii) to assess maternal tolerability of early postpartum primaquine (PQ) and tafenoquine (TQ) treatment.
Hypothesis: i) Negligible concentrations of PQ and TQ will be detected in colostrum and transitional milk, or breastfed infants, when mothers are treated with PQ or TQ and ii) Maternal administration of therapeutic doses of PQ or TQ immediately after birth does not result in clinically significant haematological or hepatorenal changes in breastfed neonates.
To do this, once eligibility is confirmed, and appropriate informed consent obtained, a sample of 60 postpartum mother-infant pairs will be recruited into one of four study treatment groups (n=15 per treatment group).
Due to the nature of the research, a conservative approach will be taken to treatment allocation, with groups (n=15) of participants to be allocated treatment doses in a stepwise design as follows: Group 1 - non-intervention (control) group; Group 2 - PQ14 (0.5 mg/kg/day for 14 days); Group 3 - PQ7 (1 mg/kg/day for 7 days); and Group 4 - TQ (300 mg single dose).
Review of mother and neonate for safety and PK procedures across all groups will be scheduled on days 0, 1, 3, 6, 8, 15, 20 and 28 (and 56 for Group 4). At each scheduled time point a symptom questionnaire (capturing both maternal symptoms and the mother's observations of her child) will be conducted, along with a physical examination of both mother and infant. Samples for PK (maternal venous blood, maternal dried blood spot, fore- and hind-breast milk, infant dried blood spot) and safety assessment (haemoglobin, methaemoglobin, hepatorenal biochemistry) will also be collected at specified time points to confirm safety and characterise the transfer and PK profile of PQ/TQ in breast milk and associated infant exposure.
After completion of procedures (Day 28 for Groups 1-3 and Day 59 for Group 4) standardized review of each mother and infant will be conducted monthly for 6 months after initial treatment to monitor P. vivax recurrence and other indicators of maternal and infant health. These study review visits will be timed to coincide with the national infant immunisation schedule at 1, 2, 3 and 6 months. Examination of the infant by study staff will complement assessment of developmental milestones, and maternal assessment could include family planning.
- Being tested
- Daily primaquine (0.5 mg/kg per day) for 14 days given with food food and water, Daily primaquine 1 mg/kg per day for 7 days given with food and water, Single-dose tafenoquine given with food and water to prevent gastrointestinal discomfort
- Keywords
- primaquine, tafenoquine, vivax malaria, pharmacokinetics, postpartum, lactation, infant exposure
- Medical subject headings
- Malaria, Vivax, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily primaquine (0.5 mg/kg per day) for 14 days given with food food and waterDrug
Also called Primacin, Primaquine phosphate
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.
Daily primaquine 1 mg/kg per day for 7 days given with food and waterDrug
Also called Primacin, Primaquine phosphate
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.
Single-dose tafenoquine given with food and water to prevent gastrointestinal discomfortDrug
Also called Tafenoquine succinate, Kodatef
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.
| Study group | Role | What they receive |
|---|---|---|
| Group1 - control | No intervention | Participants will receive no intervention at time of delivery. As per standard care in PNG, each participant will receive primaquine at 6-months postpartum (completion of study procedures). |
| Group 2 - PQ14 | Experimental | Daily oral primaquine as 0.5 mg/kg per day for 14 days, taken with food and water Receives: Drug: Daily primaquine (0.5 mg/kg per day) for 14 days given with food food and water |
| Group 3 - PQ7 | Experimental | Daily oral primaquine 1 mg/kg per day for 7 days, taken with food and water Receives: Drug: Daily primaquine 1 mg/kg per day for 7 days given with food and water |
| Group 4 - TQ | Experimental | Single dose tafenoquine as 300mg taken with food and water Receives: Drug: Single-dose tafenoquine given with food and water to prevent gastrointestinal discomfort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic: Distribution half -life
Pharmacokinetic parameters of primaquine (PQ) (and primary metabolite carboxyprimaquine) and tafenoquine (TQ) in breast milk (colostrom and transitional milk) to determine relative infant exposure. Based on drug concentrations determined from venous blood samples (mothers) and heel prick samples (infants) collected at baseline (Day 0) 1, 3, 6, 8,15, 20 and 28 (and 56 for Group 4).
Measured: Group 2 and 3: 28 days after first drug dose (PQ) and Group 4: 56 days after drug administration (TQ)
Pharmacokinetic: Termination elimination half-life
Measured: Group 2 and 3: 28 days after first drug dose (PQ) and Group 4: 56 days after drug administration (TQ).
Pharmacokinetic: Absorption half-life
Measured: Group 2 and 3: 28 days after first drug dose (PQ) and Group 4: 56 days after drug administration (TQ).
Pharmacokinetics: Clearance
Measured: Group 2 and 3: 28 days after first drug dose (PQ) and Group 4: 56 days after drug administration (TQ).
Pharmacokinetics: Volume of distribution
Measured: Group 2 and 3: 28 days after first drug dose (PQ) and Group 4: 56 days after drug administration (TQ).
Pharmacokinetics: Maximal concentration
Measured: Group 2 and 3: 28 days after first drug dose (PQ) and Group 4: 56 days after drug administration (TQ).
Pharmacokinetics: Area under concentration-time curve
Measured: Group 2 and 3: 28 days after first drug dose (PQ) and Group 4: 56 days after drug administration (TQ).
Secondary outcomes (9)
Safety: Change in haemoglobin over 28 days
Haemoglobin concentration will be measured on peripheral blood samples (HemoCue) at baseline (before drug administration) and on Days 3, 6, 8, 15, 20 and 28.
Measured: Up to 28 days
Safety: Change in haemotocrit over 28 days
Haematocrit will be measured at baseline (before drug administration), and on Days 3, 6, 8, 15, 20 and 28 using venous blood, that is drawn into a centrifuge tube and centrifuged to separate cellular components.
Measured: Up to 28 days
Safety: Change in methaemoglobin over 28 days
Methaemoglobin concentration will be measured by pulse oximetry (Masimo Rad-57 Pulse CO-Oximeter with SpMet functionality) at baseline (before drug administration), and on Days 1, 3, 6, 8, 15, 20 and 28.
Measured: Up to 28 days
Safety: Change in maternal and infant weight in kilograms over 28 days
Maternal and infant weight will be measured at all follow-up time-points (Baseline (Day 0), Days 1, 3, 6, 8, 15, 20, 28), using appropriate calibrated scales. All measurements will be recorded to the closest kilogram.
Measured: Up to 28 days
Safety: Frequency of self-reported adverse events
Measured: Up to 7 days after completion of treatment regimen
Safety: Breastfeeding behaviour
At each follow-up time-point, mothers will be asked to report the estimated duration of breast feeding (minutes) during the previous 24 hours.
Measured: Up to 14 days
Change in alanine transaminase (ALT) over 28 days
Alanine transaminase (ALT) will be evaluated using point-of-care biochemistry analysis (Fuji Dri-Chem NX600). Samples will be evaluated at baseline (before drug administration), and on Days 3, 6, 8, 15, 20 and 28.
Measured: Up to 28 days
Change in total bilirubin (TBil) over 28 days
Total bilirubin (TBil) will be evaluated using point-of-care biochemistry analysis (Fuji Dri-Chem NX600). Samples will be evaluated at baseline (before drug administration) and on Days 3, 6, 8, 15, 20 and 28.
Measured: Up to 28 days
Change in creatinine (Cr) over 28 days
Creatinine (Cr) will be evaluated using point-of-care biochemistry analysis (Fuji Dri-Chem NX600). Samples will be evaluated at at baseline (before drug administration) and on Days 3, 6, 8, 15, 20 and 28.
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study startApr 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Pharmacokinetics in Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Curtin University
- Sponsor type
- University, hospital or other
- Collaborators
- Menzies School of Health Research, Papua New Guinea Institute of Medical Research
- Responsible party
- Principal investigator, Brioni Moore, Curtin University
- Investigators
- Brioni Moore, PhD, Principal investigator, Curtin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060404
- Sponsor's protocol ID
- RES68007
- Status last verified
- Jul 2025
- First submitted
- 11 Jun 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared upon contact with the principle investigators and approval by the PNG Institute of Medical Research.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Primaquine and Tafenoquine in Lactating Women - Towards Equitable Radical Cure of Vivax Malaria
- ClinicalTrials.gov ID
- NCT07060404
- Acronym / sponsor ID
- RES68007
- Keywords
- primaquine, tafenoquine, vivax malaria, pharmacokinetics, postpartum, lactation, infant exposure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Curtin UniversityUniversity, hospital or other
- Collaborators
- Menzies School of Health Research, Papua New Guinea Institute of Medical Research
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In Papua New Guinea, administration of primaquine (PQ) or tafenoquine (TQ) to breastfeeding mothers is contraindicated during the first six months postpartum, when infants are recommended to be exclusively breastfed, because of a lack of comprehensive pharmacokinetic data on PQ/TQ neonatal and infant exposure via breast milk. The therapeutic restriction of PQ/TQ use in lactating women during the first six months postpartum effectively translates into ~10% of females being excluded from radical cure in endemic areas at any time. This is because many at risk women live in remote areas, are frequently lost to follow-up, or may have conceived again before they reattend. As a result, radical cure is rarely achieved and women are exposed to recurrent infections and cumulative risk of anaemia. Relapses may occur for years, placing subsequent pregnancies at risk and perpetuating intergenerational failure of fetal growth. They also contribute to malaria transmission, thus household and community exposure to vivax malaria.
The goal of the present study is to determine how much PQ/TQ is transferred to a suckling baby, if a mother receives a treatment course of PQ/TQ at time of delivery. We also want to confirm that this treatment is safe and has no major side effects for babies in Papua New Guinea.
The study Interventions areas follows: Group 1 - Participants receive PNG standard of care; PQ given 6-months postpartum; Group 2 - Participants receive a 14-day treatment regimen of PQ, at the standard dose prescribed in PNG for vivax radical cure (0.5 mg/kg/day for 14 days); Group 3 - Participants receive an accelerated high-dose 7-day treatment regimen of PQ, as per current WHO recommendations (1.0 mg/kg/day for 7 days); Group 4 - Participants receive a single dose of 300mg tafenoquine.
All participants will be monitored for a total duration of 6 months, with the safety, tolerability, pharmacokinetics and preliminary relapse efficacy of PQ/TQ evaluated at standardised time points over this period (Day 0, 1, 3, 6, 8, 15, 20, 28, and Month 2, 3, 4, 5 and 6). At each of these time points, participants will be asked to describe any symptoms they may be experiencing, participate in a medical examination, and provide a blood and breast milk sample for drug analysis and safety (biochemistry and haematology testing). The investigators will also collect a small blood sample (heel prick) from the infant to measure drug concentrations and safety testing.
Detailed description
Global malaria eradication requires universal and equitable access to effective antimalarial treatment. More than 2.5 billion people are at risk of infection with Plasmodium vivax. Unlike falciparum malaria, P. vivax forms dormant liver-stage parasites (hypnozoites) that can reactivate (relapse) causing recurrent febrile illness after the initial infection. Women are at increased risk of vivax malaria during pregnancy and postpartum, when they are at higher risk of P. vivax infections than P. falciparum malaria. Over 80% of these infections are relapses, rather than new infections but pregnant and lactating women cannot be treated with the available anti-relapse drugs. This is because the 8-aminoquinolones, primaquine (PQ) and tafenoquine (TQ), can cause potentially life-threatening haemolysis in glucose-6-phosphate dehydrogenase (G6PD)-deficient babies, and there is concern that the drugs are transferred in breast milk. If anti-relapse treatment could be given immediately on delivery and before discharge, it would dramatically reduce the risk of vivax relapses which currently affect ~10% of women in countries like Papua New Guinea (PNG).
This study aims to accelerate maternal access to PQ/TQ by confirming minimal transfer of PQ or TQ not only in mature breast milk (>2 weeks postpartum; current data available from a pharmacokinetic (PK) study in Thailand), but also in colostrum and transitional breast milk in the first two weeks after birth. Generating PK data for TQ is also critical. Maternal treatment could then be initiated before hospital discharge to prevent postpartum relapses and maximise benefit for health outcomes and malaria control.
This open-label study has the following objectives and hypothesis:
Primary Objective: To determine the transfer of primaquine (and primary metabolite carboxyprimaquine) and tafenoquine in breast milk (colostrum and transitional milk) and determine associated relative infant exposure.
Secondary objectives include; i) To compare haematological and hepatorenal indices in exposed and unexposed mother-infant pairs as a measure of safety, and ii) to assess maternal tolerability of early postpartum primaquine (PQ) and tafenoquine (TQ) treatment.
Hypothesis: i) Negligible concentrations of PQ and TQ will be detected in colostrum and transitional milk, or breastfed infants, when mothers are treated with PQ or TQ and ii) Maternal administration of therapeutic doses of PQ or TQ immediately after birth does not result in clinically significant haematological or hepatorenal changes in breastfed neonates.
To do this, once eligibility is confirmed, and appropriate informed consent obtained, a sample of 60 postpartum mother-infant pairs will be recruited into one of four study treatment groups (n=15 per treatment group).
Due to the nature of the research, a conservative approach will be taken to treatment allocation, with groups (n=15) of participants to be allocated treatment doses in a stepwise design as follows: Group 1 - non-intervention (control) group; Group 2 - PQ14 (0.5 mg/kg/day for 14 days); Group 3 - PQ7 (1 mg/kg/day for 7 days); and Group 4 - TQ (300 mg single dose).
Review of mother and neonate for safety and PK procedures across all groups will be scheduled on days 0, 1, 3, 6, 8, 15, 20 and 28 (and 56 for Group 4). At each scheduled time point a symptom questionnaire (capturing both maternal symptoms and the mother's observations of her child) will be conducted, along with a physical examination of both mother and infant. Samples for PK (maternal venous blood, maternal dried blood spot, fore- and hind-breast milk, infant dried blood spot) and safety assessment (haemoglobin, methaemoglobin, hepatorenal biochemistry) will also be collected at specified time points to confirm safety and characterise the transfer and PK profile of PQ/TQ in breast milk and associated infant exposure.
After completion of procedures (Day 28 for Groups 1-3 and Day 59 for Group 4) standardized review of each mother and infant will be conducted monthly for 6 months after initial treatment to monitor P. vivax recurrence and other indicators of maternal and infant health. These study review visits will be timed to coincide with the national infant immunisation schedule at 1, 2, 3 and 6 months. Examination of the infant by study staff will complement assessment of developmental milestones, and maternal assessment could include family planning.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group1 - control | No intervention | –Participants will receive no intervention at time of delivery. As per standard care in PNG, each participant will receive primaquine at 6-months postpartum (completion of study procedures). |
| Group 2 - PQ14 | Experimental | Drug: Daily primaquine (0.5 mg/kg per day) for 14 days given with food food and waterDaily oral primaquine as 0.5 mg/kg per day for 14 days, taken with food and water |
| Group 3 - PQ7 | Experimental | Drug: Daily primaquine 1 mg/kg per day for 7 days given with food and waterDaily oral primaquine 1 mg/kg per day for 7 days, taken with food and water |
| Group 4 - TQ | Experimental | Drug: Single-dose tafenoquine given with food and water to prevent gastrointestinal discomfortSingle dose tafenoquine as 300mg taken with food and water |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥18 years of age
- Both mother and infant have G6PD activity >70% (normal activity; SD Biosensor)
- They have no significant co-morbidity
- Delivered a live singleton baby within past 48-hours
- Rapid diagnostic test negative for malaria
Key exclusion criteria (8 listed)
- Either mother/infant have G6PD activity <70% (SD Biosensor)
- Either mother/infant have significant co-morbidity
- Mother did not deliver a live singleton within past 48-hours
- Mother/infant are rapid diagnostic test positive for malaria
- Mother has a history of hypersensitivity to 8-aminoquinoline drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily primaquine (0.5 mg/kg per day) for 14 days given with food food and waterAlso: Primacin, Primaquine phosphateWomen 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 | Group 2 - PQ14 |
| Daily primaquine 1 mg/kg per day for 7 days given with food and waterAlso: Primacin, Primaquine phosphateWomen 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 | Group 3 - PQ7 |
| Single-dose tafenoquine given with food and water to prevent gastrointestinal discomfortAlso: Tafenoquine succinate, KodatefWomen 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. | Drug | Group 4 - TQ |
Primary outcome
Pharmacokinetic: Distribution half -life
Time frame: Group 2 and 3: 28 days after first drug dose (PQ) and Group 4: 56 days after drug administration (TQ)
Pharmacokinetic parameters of primaquine (PQ) (and primary metabolite carboxyprimaquine) and tafenoquine (TQ) in breast milk (colostrom and transitional milk) to determine relative infant exposure. Based on drug concentrations determined from venous blood samples (mothers) and heel prick samples (infants) collected at baseline (Day 0) 1, 3, 6, 8,15, 20 and 28 (and 56 for Group 4).
Pharmacokinetic: Termination elimination half-life
Time frame: Group 2 and 3: 28 days after first drug dose (PQ) and Group 4: 56 days after drug administration (TQ).
Pharmacokinetic: Absorption half-life
Time frame: Group 2 and 3: 28 days after first drug dose (PQ) and Group 4: 56 days after drug administration (TQ).
Pharmacokinetics: Clearance
Time frame: Group 2 and 3: 28 days after first drug dose (PQ) and Group 4: 56 days after drug administration (TQ).
Pharmacokinetics: Volume of distribution
Time frame: Group 2 and 3: 28 days after first drug dose (PQ) and Group 4: 56 days after drug administration (TQ).
Pharmacokinetics: Maximal concentration
Time frame: Group 2 and 3: 28 days after first drug dose (PQ) and Group 4: 56 days after drug administration (TQ).
Pharmacokinetics: Area under concentration-time curve
Time frame: Group 2 and 3: 28 days after first drug dose (PQ) and Group 4: 56 days after drug administration (TQ).
9 secondary outcomes
Safety: Change in haemoglobin over 28 days
Time frame: Up to 28 days
Safety: Change in haemotocrit over 28 days
Time frame: Up to 28 days
Safety: Change in methaemoglobin over 28 days
Time frame: Up to 28 days
Safety: Change in maternal and infant weight in kilograms over 28 days
Time frame: Up to 28 days
Safety: Frequency of self-reported adverse events
Time frame: Up to 7 days after completion of treatment regimen
Safety: Breastfeeding behaviour
Time frame: Up to 14 days
Change in alanine transaminase (ALT) over 28 days
Time frame: Up to 28 days
Change in total bilirubin (TBil) over 28 days
Time frame: Up to 28 days
Change in creatinine (Cr) over 28 days
Time frame: Up to 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: Undecided. Data will be shared upon contact with the principle investigators and approval by the PNG Institute of Medical Research.
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A Study to Learn About the Single Dose Pharmacokinetics of Study Medicine Called Tilrekimig in Healthy Adults When Co-Mixed With rHuPH20
Healthy
Not yet recruitingPhase 1
A Study to Compare the Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety and Tolerability of Filgrastim Biosimilar and Neupogen Reference Product in Healthy Volunteers
Neutropenia (Low White Blood Cell Count)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brioni Moore, PhD principal investigator
Curtin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Daily primaquine (0.5 mg/kg per day) for 14 days given with food food and water, Daily primaquine 1 mg/kg per day for 7 days given with food and water and Single-dose tafenoquine given with food and water to prevent gastrointestinal discomfort in people with Drug Pharmacokinetics in Healthy Volunteers, run by Curtin University at 1 site in Papua New Guinea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Papua New Guinea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brioni Moore, PhD (+61 8 9266 2956, brioni.moore@curtin.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic: Distribution half -life (time frame: Group 2 and 3: 28 days after first drug dose (PQ) and Group 4: 56 days after drug administration (TQ)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.