[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621678":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":33,"centralContacts":37,"locations":43,"responsibleParty":60,"collaborators":32,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":32,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":32,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":85,"whyStopped":32,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"State University of New York - Upstate Medical University","OTHER",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Normal Metabolizers (NM)","EXPERIMENTAL","Participants with normal CYP2D6 enzyme activity receiving a single 300 milligram (mg) dose of tafenoquine.",[13],"Drug: Tafenoquine Oral Tablet",{"label":15,"type":10,"description":16,"interventionNames":17},"Intermediate Metabolizers (IM)","Participants with decreased activity of the enzyme leading to variable effects i.e., either no effect, increased adverse effects from TQ or reduced efficacy of the drug in endemic areas due to inadequate metabolism receiving a single 300mg dose of tafenoquine.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Poor Metabolizers (PM)","Participants with no enzyme activity at all, leading to a null phenotype and no drug metabolism, receiving a single 300mg dose of tafenoquine.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Ultra Metabolizers (UM)","Participants with increased enzyme activity, leading to accelerated metabolism, receiving 300mg dose of tafenoquine",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Tafenoquine Oral Tablet","Single, 300mg dose",[15,9,19,23],null,[34],{"name":35,"affiliation":5,"role":36},"Michele Spring, MD","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":32,"email":42},"Keely Terrillion","CONTACT","315-464-9869","trials@upstate.edu",[44],{"facility":45,"status":32,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"SUNY Upstate Medical University, Upstate Global Health Institute","East Syracuse","New York","13057","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-76.07853,43.06534,{"lat":55,"lon":54},[58,59],{"name":39,"role":40,"phone":41,"phoneExt":32,"email":42},{"name":35,"role":36,"phone":32,"phoneExt":32,"email":32},{"type":61,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100621678","early-phase-1-pharmacokinetic-pk-study-of-tafenoquine-in-healthy-adults-100621678",false,"NCT07373743","Pharmacokinetic (PK) Study of Tafenoquine in Healthy Adults","Inclusion Criteria:\n\n1. Age 18-65 at the time of consent, weighing between 132 and 250 pounds\n2. Ability and willingness to sign informed consent\n3. Available for the study period\n4. Willing to use contraception for the duration of the study\n5. Agree not to take over the counter antioxidants, vitamin C or vitamin E, 2 weeks prior to dosing and 7 days post dosing\n\nExclusion Criteria:\n\n1. Women: positive urine pregnancy test at screening or day of dosing\n2. Women who are lactating or intend to become pregnant during the study period.\n3. Acute or chronic clinically significant hematologic, pulmonary, cardiovascular, hepatic, or renal functional abnormality as determined by medical history, physical examination or laboratory screening.\n4. History of allergic reaction to tafenoquine or primaquine.\n5. Scheduled receipt of any vaccine 1 week prior to or after 4 weeks tafenoquine dosing. Routine COVID and influenza vaccination will be allowed outside of this timeframe.\n6. Currently taking metformin, dofeltilide or other medication with known multidrug and toxin extrusion enzyme (MATE) metabolism.\n7. Known or suspected congenital or acquired immunodeficiency; or receipt of immunomodulation therapy such as anti-cancer chemotherapy or radiation therapy.\n8. Diagnosis with Bipolar Disorder or Schizophrenia, hospitalization in the past year for a mental health disorder, or any other psychiatric condition, which in the opinion of the investigator prevents the participant from participating in the study.\n9. Participants with hemoglobin, Creatinine, BUN, and Albumin of grade 2 or greater. Participants with eGFR \\\u003C90mL\u002Fmin\u002F1.73m2; ALT \\>1.5x ULN, or AST \\>1.5x ULN. Any exclusionary lab abnormality may be repeated once. If a repeat screening blood test is performed, only the result of the second test will be reviewed and used to determine eligibility.\n10. Positive HIV, hepatitis B surface antigen or hepatitis C.\n11. G6PD result not normal or \\\u003C 70% activity\n12. Significant screening physical examination abnormalities or chronic medical condition that in the opinion of the investigator may impact participant safety, including BMI \\> 35kg\u002Fm2\n13. Participation (active or follow-up phase) or planned participation in another vaccine, or drug, in the 4 weeks prior to or during the trial\n14. Beliefs that bar the administration of blood products or transfusions\n15. Clinician discretion",true,"ALL","18 Years","65 Years",{"count":73,"type":74},20,"ESTIMATED","INTERVENTIONAL",[77],"EARLY_PHASE1","The goal of this clinical trial is to learn how people's different genetic makeups affects how their bodies convert the FDA approved drug ARAKODA (tafenoquine) to its active form. Tafenoquine is a drug that is taken to prevent malaria for people traveling to areas where there is malaria. This trial will be in healthy participants age 18-65.",[80],"Pharmacokinetic in Normal Population",[82,83,84],"Tafenoquine","CYP2D6","Pharmacokinetic","NOT_YET_RECRUITING","2026-03-18",{"date":88,"type":89},"2026-03-20","ACTUAL",{"date":91,"type":74},"2026-05",{"date":93,"type":74},"2027-03",{"name":5,"class":6},1]