Pharmacokinetics of TafenoquinePhase 4NCT07052162
Investigating the Pharmacokinetics of Tafenoquine in Healthy Papua New Guinean Children
A Phase 4 study testing Single dose tafenoquine (10 mg/kg) given with water and Single dose tafenoquine (10 mg/kg) given with fat in people with Pharmacokinetics of Tafenoquine, run by Curtin University at 1 site in Papua New Guinea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics of Tafenoquine
- What is being tested?
- Single dose tafenoquine (10 mg/kg) given with water and Single dose tafenoquine (10 mg/kg) given with fat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePapua New Guinea
- Study dates
- 20 Oct 2025to Mar 2026
- Phase
- Phase 4
- 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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
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, 1 recruiting
- Recruiting
Alexishafen Health Centre
Madang, Madang Province, MP511
Paula Tesine, MD, +675 434 02058, paula.tesine@pngimr.org.pg
About this study
Official title: Safety, Pharmacokinetics, and Preliminary Efficacy of Tafenoquine for the Treatment of Vivax Malaria in Papua New Guinean Children
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.
Read the detailed description
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:
- To evaluate the role of fat on the bioavailability of tafenoquine
- To assess the safety of tafenoquine in PNG children
- To assess the tolerability of tafenoquine in PNG children
The investigators hypothesise that:
- A single dose of tafenoquine (10 mg/kg) is safe in PNG children
- Co-administration of tafenoquine with fat will improve drug bioavailability
- Cut or crushed tablets will not be well tolerated, although tolerability will improve with administration of whole tablets
- Conditions
- Pharmacokinetics of Tafenoquine
- Being tested
- Single dose tafenoquine (10 mg/kg) given with water, Single dose tafenoquine (10 mg/kg) given with fat
- Keywords
- tafenoquine, vivax malaria, pharmacokinetics, children
- Medical subject headings
- Malaria, Vivax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single dose tafenoquine (10 mg/kg) given with waterDrug
Also called TQ, Tafenoquine succinate, Kodatef
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
Single dose tafenoquine (10 mg/kg) given with fatDrug
Also called TQ, Tafenoquine succinate, Kodatef
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
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Single-dose tafenoquine as 10 mg/kg taken with water and a low-fat meal (3 plain cracker biscuits; 2% fat) Receives: Drug: Single dose tafenoquine (10 mg/kg) given with water |
| Group B | Experimental | 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). Receives: Drug: Single dose tafenoquine (10 mg/kg) given with fat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 56-days after drug administration
Pharmacokinetic: Terminal elimination half-life
Measured: 56-days after drug administration
Pharmacokinetic: Absorption half-life
Measured: 56-days after drug administration
Pharmacokinetics: Clearance
Measured: 56-days after drug administration
Pharmacokinetics: Volume of distribution
Measured: 56-days after drug administration
Pharmacokinetics: Maximal concentration
Measured: 56-days after drug administration
Pharmacokinetics: Area under concentration-time curve
Measured: 56-days after drug administration
Secondary outcomes (6)
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:
- 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.
Measured: 28-days from drug administration
Safety: Change in methaemoglobin over 28 days
Measured: 28-days from drug administration
Safety: Change in hepatorenal function over 7 days
Measured: 7-days from drug administration
Safety: Change in rate corrected QTc over 28 days
Measured: 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).
Measured: 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.
Measured: 56-days after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start20 Oct 2025
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetics of TafenoquineStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Curtin University
- Sponsor type
- University, hospital or other
- Collaborators
- Papua New Guinea Institute of Medical Research, The University of Western Australia
- Responsible party
- Sponsor
- Investigators
- Brioni R Moore, PhD, Principal investigator, Curtin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052162
- Sponsor's protocol ID
- RES67418
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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
- Safety, Pharmacokinetics, and Preliminary Efficacy of Tafenoquine for the Treatment of Vivax Malaria in Papua New Guinean Children
- ClinicalTrials.gov ID
- NCT07052162
- Acronym / sponsor ID
- RES67418
- Conditions
- Pharmacokinetics of Tafenoquine
- Keywords
- tafenoquine, vivax malaria, pharmacokinetics, children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Curtin UniversityUniversity, hospital or other
- Collaborators
- Papua New Guinea Institute of Medical Research, The University of Western Australia
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 4 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.
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.
Detailed description
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:
- To evaluate the role of fat on the bioavailability of tafenoquine
- To assess the safety of tafenoquine in PNG children
- To assess the tolerability of tafenoquine in PNG children
The investigators hypothesise that:
- A single dose of tafenoquine (10 mg/kg) is safe in PNG children
- Co-administration of tafenoquine with fat will improve drug bioavailability
- Cut or crushed tablets will not be well tolerated, although tolerability will improve with administration of whole tablets
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Single dose tafenoquine (10 mg/kg) given with waterSingle-dose tafenoquine as 10 mg/kg taken with water and a low-fat meal (3 plain cracker biscuits; 2% fat) |
| Group B | Experimental | Drug: Single dose tafenoquine (10 mg/kg) given with fatSingle-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). |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Single dose tafenoquine (10 mg/kg) given with waterAlso: TQ, Tafenoquine succinate, KodatefParticipants 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 | Group A |
| Single dose tafenoquine (10 mg/kg) given with fatAlso: TQ, Tafenoquine succinate, KodatefSingle-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 | Drug | Group B |
Primary outcome
Pharmacokinetic: Distribution half-life
Time frame: 56-days after drug administration
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.
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
6 secondary outcomes
Safety: Change in haemoglobin over 28 days
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
Time frame: 1-day following drug administration
Safety and tolerability: Number of participants with treatment-related adverse events as assessed by standardised questionnaire
Time frame: 56-days after drug administration
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: 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.
Related trials for Pharmacokinetics of Tafenoquine
Not yet recruitingPhase 2
Tafenoquine Drug Levels in Small Children
Plasmodium Vivax Malaria, Vivax Malaria
Not yet recruitingPhase 2/3
Postpartum 8-aminoquinoline Breast Milk Study
Drug Pharmacokinetics in Healthy Volunteers
Not yet recruitingPhase 4
Investigating the Pharmacology of Tafenoquine in Papua New Guinean Children With Uncomplicated Malaria
Uncomplicated Malaria
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 R 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 4 study testing Single dose tafenoquine (10 mg/kg) given with water and Single dose tafenoquine (10 mg/kg) given with fat in people with Pharmacokinetics of Tafenoquine, 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 6 inclusion and 6 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: looking for participants now, 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 R 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: 56-days after drug administration). 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.