Phase 1Completed
Pharmacokinetics of Antituberculosis Drugs in Breastfeeding Women (PRiMe)
Plasma and Breastmilk Exposures to Antituberculosis Drugs in Breastfeeding Women: an Open-label, Randomized, Six-arm, Single-dose, Pharmacokinetic Study
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre (Academic or other)
- Enrollment
- 60 enrolled
- Conditions
- Tuberculosis Infection; Healthy Volunteer; Breastfeeding
- Interventions
- Standard dose rifampicin; High dose rifampicin; Standard dose isoniazid; Standard dose levofloxacin; Standard dose rifapentine; Standard dose bedaquiline
- Ages
- adults, older adults
- Registry
- NCT07069582
Full record on ClinicalTrials.gov
From the registry
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). *…
Primary outcomes
- Area under the concentration-time curve from 0 to 24 hours (AUC0-24)
- Peak concentration (Cmax)
History
Last registry update
Primary completion
Started
Registered