[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596952":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":34,"centralContacts":38,"locations":44,"responsibleParty":64,"collaborators":66,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":42,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":42,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":47,"whyStopped":42,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Curtin University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A","EXPERIMENTAL","Single-dose tafenoquine as 10 mg\u002Fkg taken with water and a low-fat meal (3 plain cracker biscuits; 2% fat)",[13],"Drug: Single dose tafenoquine (10 mg\u002Fkg) given with water",{"label":15,"type":10,"description":16,"interventionNames":17},"Group B","Single-dose tafenoquine as 10mg\u002Fkg taken with 250 mL chocolate flavoured milk (9% fat) and a low-fat meal (3 plain cracker biscuits; 2% fat).",[18],"Drug: Single dose tafenoquine (10 mg\u002Fkg) given with fat",[20,29],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Single dose tafenoquine (10 mg\u002Fkg) given with water","Participants will receive single-dose TQ as 10 mg\u002Fkg 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 Children vomiting within the first 30 minutes of treatment will be withdrawn",[9],[26,27,28],"TQ","Tafenoquine succinate","Kodatef",{"type":21,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Single dose tafenoquine (10 mg\u002Fkg) given with fat","Single-dose TQ as 10 mg\u002Fkg 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",[15],[26,27,28],[35],{"name":36,"affiliation":5,"role":37},"Brioni R Moore, PhD","PRINCIPAL_INVESTIGATOR",[39],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","+61 8 9266 2956",null,"brioni.moore@curtin.edu.au",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Alexishafen Health Centre","RECRUITING","Madang","Madang Province","MP511","Papua New Guinea","PG",{"type":54,"coordinates":55},"Point",[56,57],145.78695,-5.22152,{"lat":57,"lon":56},[60],{"name":61,"role":40,"phone":62,"phoneExt":42,"email":63},"Paula Tesine, MD","+675 434 02058","paula.tesine@pngimr.org.pg",{"type":65,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR",[67,70],{"name":68,"class":69},"Papua New Guinea Institute of Medical Research","OTHER_GOV",{"name":71,"class":6},"The University of Western Australia","100596952","phase-4-investigating-the-pharmacokinetics-of-tafenoquine-in-healthy-papua-new-guinean-children-100596952",false,"NCT07052162","Investigating the Pharmacokinetics of Tafenoquine in Healthy Papua New Guinean Children","Safety, Pharmacokinetics, and Preliminary Efficacy of Tafenoquine for the Treatment of Vivax Malaria in Papua New Guinean Children","Inclusion Criteria:\n\n* have a normal glucose-6-phosphate-dehydrogenase (G6PD) activity (\\>70% enzyme activity) as confirmed by quantitative SD Biosensor\n* are Rapid Diagnostic Test negative for malaria\n* have not received treatment with any antimalarial in the previous 4-weeks\n* have no signs or symptoms of significant morbidity\n* have no history of hypersensitivity to primaquine\n* are able to attend all scheduled follow-up visits\n\nExclusion Criteria:\n\n* have G6PD activity \\\u003C70%\n* test positive for malaria by rapid diagnostic test\n* have receive treatment with an antimalarial in the previous 4-weeks\n* have signs or symptoms of significant morbidities\n* have a history of primaquine related hypersensitivity\n* cannot, or are not willing, to attend all scheduled follow-up visits",true,"ALL","5 Years","12 Years",{"count":84,"type":85},30,"ESTIMATED","INTERVENTIONAL",[88],"PHASE4","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.\n\nThe 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\u002Fkg\u002Fday) 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.\n\nThe overall aim of the study is to characterise the pharmacokinetic profile of tafenoquine (and primary metabolite) in Papua New Guinean children.",[91],"Pharmacokinetics of Tafenoquine",[93,94,95,96],"tafenoquine","vivax malaria","pharmacokinetics","children","2026-03-16",{"date":99,"type":100},"2026-03-18","ACTUAL",{"date":102,"type":100},"2025-10-20",{"date":104,"type":85},"2026-03",{"name":5,"class":6},1]