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:
* Arm A: Single-dose rifampicin at 10 mg/kg body weight (RIF10). * Arm B: Single-dose rifampicin at 20 mg/kg body weight (RIF20). * Arm C: Single-dose isoniazid at 5 mg/kg body weight (INH5). * Arm D: Single-dose levofloxacin at 10-15 mg/kg body weight (LFX10-15). * Arm E: Single-dose rifapentine at 10 mg/kg body weight (RPT10). * Arm F: Single-dose bedaquiline at 400 mg (BDQ400).
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.
Have a body weight between 25 and 100 kg.
Provide written informed consent.
Grade 3-4 abnormalities on baseline blood chemistry tests, including serum alanine aminotransferase (ALT), creatinine, or blood glucose.
Grade 3-4 abnormalities on baseline hematological tests, including white blood count, platelets, or hemoglobin.
Contraindications or history of hypersensitivity/intolerance to rifampicin, isoniazid, levofloxacin, rifapentine, or bedaquiline.
Taking concomitant medications for TB disease, TB infection, diabetes mellitus, hypertension, HIV, cardiac disease or any other chronic diseases.
Parallel
Standard dose rifampicin
DrugSingle-dose rifampicin at 10 mg/kg body weight
High dose rifampicin
DrugSingle-dose rifampicin at 20 mg/kg body weight
Standard dose isoniazid
DrugSingle-dose isoniazid at 5 mg/kg body weight
Standard dose levofloxacin
DrugSingle-dose levofloxacin at 10-15 mg/kg body weight
Standard dose rifapentine
DrugSingle-dose rifapentine at 10 mg/kg body weight
Standard dose bedaquiline
DrugSingle-dose bedaquiline at 400 mg
6
Treatment groupsSee each treatment group below.
Area under the concentration-time curve from 0 to 24 hours (AUC0-24)
Total drug exposures in plasma and breast milk, i.e., the total area under the concentration-time curve from 0 to 24 hours (AUC0-24) after administration of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline.
Peak concentration (Cmax)
Peak concentration (Cmax) in plasma and breast milk after administration of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline.
Time to Cmax (Tmax)
Time to Cmax (Tmax) in plasma and breast milk after administration of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline.
Apparent clearance (CL/F)
Apparent clearance (CL/F) in plasma and breast milk after administration of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline.
Apparent volume of distribution (Vd/F)
Apparent volume of distribution (Vd/F) in plasma and breast milk after administration of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline.
Half-life (t1/2)
Half-life (t1/2) in plasma and breast milk after administration of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline.
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McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead sponsor
Faculty of Medicine Universitas Padjadjaran
Collaborator
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