[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598291":3},{"organization":4,"armGroups":7,"interventions":39,"overallOfficials":71,"centralContacts":76,"locations":87,"responsibleParty":113,"collaborators":116,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":128,"sex":129,"minAge":130,"maxAge":85,"enrollmentInfo":131,"targetDuration":85,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":142,"overallStatus":153,"whyStopped":85,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER",[8,14,19,24,29,34],{"label":9,"type":10,"description":11,"interventionNames":12},"10 mg\u002Fkg rifampicin (RIF10)","EXPERIMENTAL","Single-dose rifampicin at 10 mg\u002Fkg body weight",[13],"Drug: Standard dose rifampicin",{"label":15,"type":10,"description":16,"interventionNames":17},"20 mg\u002Fkg rifampicin (RIF20)","Single-dose rifampicin at 20 mg\u002Fkg body weight",[18],"Drug: High dose rifampicin",{"label":20,"type":10,"description":21,"interventionNames":22},"5 mg\u002Fkg isoniazid (INH5)","Single-dose isoniazid at 5 mg\u002Fkg body weight",[23],"Drug: Standard dose isoniazid",{"label":25,"type":10,"description":26,"interventionNames":27},"10-15 mg\u002Fkg levofloxacin (LFX10-15)","Single-dose levofloxacin at 10-15 mg\u002Fkg body weight",[28],"Drug: Standard dose levofloxacin",{"label":30,"type":10,"description":31,"interventionNames":32},"10 mg\u002Fkg rifapentine (RPT10)","Single-dose rifapentine at 10 mg\u002Fkg body weight",[33],"Drug: Standard dose rifapentine",{"label":35,"type":10,"description":36,"interventionNames":37},"400 mg bedaquiline (BDQ400)","Single-dose bedaquiline at 400 mg",[38],"Drug: Standard dose bedaquiline",[40,46,51,56,61,66],{"type":41,"name":42,"description":11,"armGroupLabels":43,"otherNames":44},"DRUG","Standard dose rifampicin",[9],[45],"RIF10",{"type":41,"name":47,"description":16,"armGroupLabels":48,"otherNames":49},"High dose rifampicin",[15],[50],"RIF20",{"type":41,"name":52,"description":21,"armGroupLabels":53,"otherNames":54},"Standard dose isoniazid",[20],[55],"INH5",{"type":41,"name":57,"description":26,"armGroupLabels":58,"otherNames":59},"Standard dose levofloxacin",[25],[60],"LFX10-15",{"type":41,"name":62,"description":31,"armGroupLabels":63,"otherNames":64},"Standard dose rifapentine",[30],[65],"RPT10",{"type":41,"name":67,"description":36,"armGroupLabels":68,"otherNames":69},"Standard dose bedaquiline",[35],[70],"BDQ400",[72],{"name":73,"affiliation":74,"role":75},"Dick Menzies, MD","Research Institute of the McGill University Health Centre, Montreal, Canada","PRINCIPAL_INVESTIGATOR",[77,82],{"name":73,"role":78,"phone":79,"phoneExt":80,"email":81},"CONTACT","514-934-1934","32128","dick.menzies@mcgill.ca",{"name":83,"role":78,"phone":84,"phoneExt":85,"email":86},"Fajri Gafar, PhD","514-248-8108",null,"fajri.gafar@mail.mcgill.ca",[88],{"facility":89,"status":85,"city":90,"state":91,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"Universitas Padjadjaran, Klinik Penelitian Tuberculosis (TB Research Clinic)","Bandung","West Java","40161","Indonesia","ID",{"type":96,"coordinates":97},"Point",[98,99],107.60694,-6.92222,{"lat":99,"lon":98},[102,106,110,111],{"name":103,"role":78,"phone":104,"phoneExt":85,"email":105},"Rovina Ruslami, MD, PhD","+62-813-4234-0336","n.ruslami@gmail.com",{"name":107,"role":78,"phone":108,"phoneExt":85,"email":109},"Vycke Yunivita, MD, PhD","+62-811-237-532","v.yunivita@unpad.ac.id",{"name":103,"role":75,"phone":85,"phoneExt":85,"email":85},{"name":107,"role":112,"phone":85,"phoneExt":85,"email":85},"SUB_INVESTIGATOR",{"type":75,"investigatorFullName":114,"investigatorTitle":115,"investigatorAffiliation":5,"oldNameTitle":85,"oldOrganization":85},"Dick Menzies","Professor",[117],{"name":118,"class":119},"Faculty of Medicine Universitas Padjadjaran","UNKNOWN","100598291","phase-1-pharmacokinetics-of-antituberculosis-drugs-in-breastfeeding-women-100598291",false,"NCT07069582","Pharmacokinetics of Antituberculosis Drugs in Breastfeeding Women","Plasma and Breastmilk Exposures to Antituberculosis Drugs in Breastfeeding Women: an Open-label, Randomized, Six-arm, Single-dose, Pharmacokinetic Study","PRiMe","Inclusion Criteria:\n\nParticipants may enter the study if all of the following apply:\n\n1. Healthy breastfeeding women aged 18 years or older, with a minimum of 3 months and a maximum of 24 months after delivery of a healthy baby, and are not currently diagnosed with either TB infection or TB disease.\n2. Have a body weight between 25 and 100 kg.\n3. Provide written informed consent.\n\nExclusion Criteria:\n\nParticipants may not enter the study if any of the following criteria apply:\n\n1. Grade 3-4 abnormalities on baseline blood chemistry tests, including serum alanine aminotransferase (ALT), creatinine, or blood glucose.\n2. Grade 3-4 abnormalities on baseline hematological tests, including white blood count, platelets, or hemoglobin.\n3. Contraindications or history of hypersensitivity\u002Fintolerance to rifampicin, isoniazid, levofloxacin, rifapentine, or bedaquiline.\n4. Taking concomitant medications for TB disease, TB infection, diabetes mellitus, hypertension, HIV, cardiac disease or any other chronic diseases.\n5. Having a breastfed infant who was diagnosed with TB infection or TB disease and is currently on treatment.\n6. Pregnancy\n7. Have an active, acute illness at the time of study enrolment.",true,"FEMALE","18 Years",{"count":132,"type":133},60,"ESTIMATED","INTERVENTIONAL",[136],"PHASE1","This study is a sub-study of the SSTARLET trial (NCT06498414). The overall aim is to assess the pharmacokinetic profiles after taking a single dose of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline in breastfeeding women and the excretion of these drugs in breast milk, with the hope of including breastfeeding women in future clinical trials of TPT, including expanding the inclusion criteria of the SSTARLET trial. In this study, healthy breastfeeding women who fulfill the eligibility criteria will be enrolled from several primary health care centers in Bandung, which will be referred to the TB Research Clinic of the Universitas Padjadjaran, Bandung, Indonesia. Ten participants will be randomized to each of the following six study arms:\n\n* Arm A: Single-dose rifampicin at 10 mg\u002Fkg body weight (RIF10).\n* Arm B: Single-dose rifampicin at 20 mg\u002Fkg body weight (RIF20).\n* Arm C: Single-dose isoniazid at 5 mg\u002Fkg body weight (INH5).\n* Arm D: Single-dose levofloxacin at 10-15 mg\u002Fkg body weight (LFX10-15).\n* Arm E: Single-dose rifapentine at 10 mg\u002Fkg body weight (RPT10).\n* Arm F: Single-dose bedaquiline at 400 mg (BDQ400).",[139,140,141],"Tuberculosis Infection","Healthy Volunteer","Breastfeeding",[143,144,145,146,147,148,149,150,151,152],"Tuberculosis infection","Latent tuberculosis infection","TBI","LTBI","Breastfeeding women","Rifampicin","Levofloxacin","Rifapentine","Isoniazid","Bedaquiline","NOT_YET_RECRUITING","2026-02-06",{"date":156,"type":157},"2026-02-10","ACTUAL",{"date":159,"type":133},"2026-04-01",{"date":161,"type":133},"2026-10-31",{"name":5,"class":6},1]