Trial reportAntimicrobial agents and chemotherapy2014
Population pharmacokinetics of bedaquiline (TMC207), a novel antituberculosis drug.
Trial report in Antimicrobial agents and chemotherapy, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 61 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
61 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Population pharmacokinetics of bedaquiline: a systematic review.European journal of clinical pharmacology · 2025Pooled it
- Pharmacokinetics, bactericidal activity and toxicity of short oral regimens for rifampicin-resistant tuberculosis treatment.Nature communications · 2026Trial
- Effect of HIV on bedaquiline and delamanid pharmacokinetics in patients with multidrug-resistant TB.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2025Trial
- Population pharmacokinetic and exposure-response study of a novel anti-tuberculosis drug to inform its dosage design in phase III clinical trial.European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences · 2025Trial
- A Semimechanistic Model of the Bactericidal Activity of High-Dose Isoniazid against Multidrug-Resistant Tuberculosis: Results from a Randomized Clinical Trial.American journal of respiratory and critical care medicine · 2021Trial
- Population Pharmacokinetic Analysis of Bedaquiline-Clarithromycin for Dose Selection Against Pulmonary Nontuberculous Mycobacteria Based on a Phase 1, Randomized, Pharmacokinetic Study.Journal of clinical pharmacology · 2021Trial
- Population Pharmacokinetics of Bedaquiline and Metabolite M2 in Patients With Drug-Resistant Tuberculosis: The Effect of Time-Varying Weight and Albumin.CPT: pharmacometrics & systems pharmacology · 2016Trial
- Impact of lopinavir-ritonavir or nevirapine on bedaquiline exposures and potential implications for patients with tuberculosis-HIV coinfection.Antimicrobial agents and chemotherapy · 2014Trial
- We Are Underprepared for Bedaquiline Resistance: A Call for Clinical and Programmatic Readiness.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Article
- Bedaquiline resistance: a predictable consequence of a game-changing drug?ASM case reports · 2026Article
- Cerebrospinal Fluid Concentrations of Bedaquiline, Pretomanid, and Linezolid During Curative Treatment of Fluoroquinolone-Resistant Pre-Extensively Drug-Resistant Tuberculous Meningitis.Open forum infectious diseases · 2026Article
- Oral milk exosome-PLGA nanoparticles enhance anti-tuberculosis efficacy of PBTZ169 and bedaquiline.iScience · 2026Article
- Exposure-QTc modeling of bedaquiline, pretomanid, and clofazimine in adults with tuberculosis.Antimicrobial agents and chemotherapy · 2026Article
- Population pharmacokinetics of TBAJ-587 and its main metabolites-Evaluation of different loading dose strategies and early dose selection.British journal of clinical pharmacology · 2026Article
- Regional absorption of talinolol mediated by intestinal transporters: insights from PBPK modeling analysis.Frontiers in pharmacology · 2026Article
- Bedaquiline Resistance: A Looming Global Threat in Tuberculosis Management.Current microbiology · 2025Review
- The Kinetics of Bedaquiline Diffusion in Tuberculous Cavities Open a Window for the Emergence of Resistance.The Journal of infectious diseases · 2025Article
- Study protocol for a duration-randomized clinical trial to determine the optimal length of treatment for multidrug-resistant tuberculosis with a 5-drug regimen: The DRAMATIC trial.Contemporary clinical trials · 2025Article
- Clinical Pharmacokinetics of Antitubercular Drugs in the Overweight and Obese Population: Implications for Dosage Adjustments.Clinical pharmacokinetics · 2025Review
- Pharmacology of emerging drugs for the treatment of multi-drug resistant tuberculosis.Journal of clinical tuberculosis and other mycobacterial diseases · 2024Review
1 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Bedaquiline is a novel agent for the treatment of pulmonary multidrug-resistant Mycobacterium tuberculosis infections, in combination with other agents. The objective of this study was to develop a population pharmacokinetic (PK) model for bedaquiline to describe the concentration-time data from phase I and II studies in healthy subjects and patients with drug-susceptible or multidrug-resistant tuberculosis (TB). A total of 5,222 PK observations from 480 subjects were used in a nonlinear mixed-effects modeling approach. The PK was described with a 4-compartment disposition model with dual zero-order input (to capture dual peaks observed during absorption) and long terminal half-life (t1/2). The model included between-subject variability on apparent clearance (CL/F), apparent central volume of distribution (Vc/F), the fraction of dose via the first input, and bioavailability (F). Bedaquiline was widely distributed, with apparent volume at steady state of >10,000 liters and low clearance. The long terminal t1/2 was likely due to redistribution from the tissue compartments. The final covariate model adequately described the data and had good simulation characteristics. The CL/F was found to be 52.0% higher for subjects of black race than that for subjects of other races, and Vc/F was 15.7% lower for females than that for males, although their effects on bedaquiline exposure were not considered to be clinically relevant. Small differences in F and CL/F were observed between the studies. The residual unexplained variability was 20.6% and was higher (27.7%) for long-term phase II studies.
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