A Phase 1 interventional study of Standard dose rifampicin and High dose rifampicin in Tuberculosis Infection, Healthy Volunteer and Breastfeeding, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Not yet recruiting at 1 site in Indonesia. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Phase 1, Interventional, and Treatment
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:
Pregnant and breastfeeding women have been largely excluded from recent and ongoing clinical trials due to ethical concerns, limiting their access to the latest advancements in tuberculosis (TB) therapy. To support the development of short, effective tuberculosis preventive treatment (TPT) regimens lasting 1-2 months, a phase 2 adaptive clinical trial (SSTARLET trial) is being planned. This trial will evaluate three experimental regimens: two months of daily double-dose rifampicin; one month of daily levofloxacin and rifapentine; and either one month of daily isoniazid and rifapentine or a bedaquiline-containing regimen. The comparator will be the current standard of four months of daily rifampicin. The safest and shortest regimen will be selected for progression to a phase 3 trial. Inclusion of breastfeeding women in future trials of these regimens is intended; however, limited pharmacokinetic (PK) and safety data exist regarding the excretion of these drugs into breast milk, which is necessary to support their use in this population.
The current study aims to establish the PK profiles 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. The specific objective of the study is to describe the PK profiles after a single dose of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline in plasma and breast milk of breastfeeding women.
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.
The primary outcomes in this study are the total drug exposure, i.e., the area under the concentration-time curve from 0 to 24 hours after drug administration (AUC0-24) and peak concentration (Cmax) of single doses of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline in plasma and breastmilk of breastfeeding women, including the breast milk/plasma ratios for AUC0-24 and Cmax to estimate the external exposure of the drugs to breastfed infants. The secondary outcomes are PK measures of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline other than AUC0-24 and Cmax, including time to Cmax (Tmax), elimination rate constant (Ke), elimination half-life (t1/2), apparent clearance (CL/F), and apparent volume of distribution (Vd/F) in plasma and breast milk of breastfeeding women.
The study design is an open-label, randomized, six-arm, single-dose, intensive PK study, that will be performed at the TB Research Clinic of the Universitas Padjadjaran, Bandung, Indonesia. Six oral drug dosages will be evaluated: rifampicin 10 mg/kg (RIF10), rifampicin 20 mg/kg (RIF20), levofloxacin 10-15 mg/kg (LFX10-15), rifapentine 10 mg/kg (RPT10), isoniazid 5 mg/kg (INH5), and bedaquiline 400 mg (BDQ400). Simple randomization will be performed, with a ratio of 1:1:1:1:1:1 for RIF10, RIF20, LFX10-15, RPT10, INH5, and BDQ400. Venous blood and breastmilk samples will be collected for PK assessments of each of the study drugs. Ten participants will be assigned to each arm, with a total participants of 60.
199 studies on the registry are indexed under Latent Tuberculosis; 46 are open to participants now.
This study's planned enrollment of 60 is below the median of 310 across 115 interventional studies indexed under Latent Tuberculosis.
Browse Latent Tuberculosis studies →McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 414 studies on the registry; 106 are open to participants now.
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Participants may enter the study if all of the following apply:
Exclusion Criteria:
Participants may not enter the study if any of the following criteria apply:
Single-dose rifampicin at 10 mg/kg body weight
Drug: Standard dose rifampicin
Single-dose rifampicin at 20 mg/kg body weight
Drug: High dose rifampicin
Single-dose isoniazid at 5 mg/kg body weight
Drug: Standard dose isoniazid
Single-dose levofloxacin at 10-15 mg/kg body weight
Drug: Standard dose levofloxacin
Single-dose rifapentine at 10 mg/kg body weight
Drug: Standard dose rifapentine
Single-dose bedaquiline at 400 mg
Drug: Standard dose bedaquiline
Single-dose rifampicin at 10 mg/kg body weight
Also known as: RIF10
Single-dose rifampicin at 20 mg/kg body weight
Also known as: RIF20
Single-dose isoniazid at 5 mg/kg body weight
Also known as: INH5
Single-dose levofloxacin at 10-15 mg/kg body weight
Also known as: LFX10-15
Single-dose rifapentine at 10 mg/kg body weight
Also known as: RPT10
Single-dose bedaquiline at 400 mg
Also known as: BDQ400
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.
Time frame: Day 1 following single-dose drug administration
Peak concentration (Cmax)
Peak concentration (Cmax) in plasma and breast milk after administration of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline.
Time frame: Day 1 following single-dose drug administration
Time to Cmax (Tmax)
Time to Cmax (Tmax) in plasma and breast milk after administration of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline.
Time frame: Day 1 following single-dose drug administration
Apparent clearance (CL/F)
Apparent clearance (CL/F) in plasma and breast milk after administration of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline.
Time frame: Day 1 following single-dose drug administration
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.
Time frame: Day 1 following single-dose drug administration
Half-life (t1/2)
Half-life (t1/2) in plasma and breast milk after administration of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline.
Time frame: Day 1 following single-dose drug administration
Plan to share: Yes — Protocol and consent form will be available for data sharing once approved by research ethical review board. A detailed plan for data sharing of other study documents and/or data is under definition and will be posted during the study.
Supporting information: Study protocol, Icf
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This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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McGill University Health Centre/Research Institute of the McGill University Health Centre