ArticleClinical pharmacology and therapeutics2012
Safety and pharmacokinetics of escalating daily doses of the antituberculosis drug rifapentine in healthy volunteers.
Article in Clinical pharmacology and therapeutics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 51 papers, 2 of them syntheses 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.
TBTC Study 31 PK/PD: Population Pharmacokinetic and Pharmacodynamic Study of Efficacy and Safety of High-Dose Rifapentine and Moxifloxacin for Treatment of Tuberculosis in the Study 31 Treatment Trial: Intensive PK Sampling
Shortened Regimen for Drug-susceptible TB in Children
Who cites it
51 citing papers in PubMed, 2 syntheses or guidelines pooled it, 89 citations in OpenAlex.
- Comparative efficacy and safety of high-dose rifamycin regimens for tuberculosis treatment: a Bayesian network meta-analysis.BMJ open · 2025Pooled it
- Rifapentine Population Pharmacokinetics and Dosing Recommendations for Latent Tuberculosis Infection.American journal of respiratory and critical care medicine · 2020Pooled it
- Efficacy and Safety of Higher Doses of Levofloxacin for Multidrug-resistant Tuberculosis: A Randomized, Placebo-controlled Phase II Clinical Trial.American journal of respiratory and critical care medicine · 2025Trial
- Risk-stratified treatment for drug-susceptible pulmonary tuberculosis.Nature communications · 2024Trial
- Decreased plasma rifapentine concentrations associated with AADAC single nucleotide polymorphism in adults with tuberculosis.The Journal of antimicrobial chemotherapy · 2021Trial
- Nevirapine pharmacokinetics in HIV-infected persons receiving rifapentine and isoniazid for TB prevention.The Journal of antimicrobial chemotherapy · 2021Trial
- Cytokine-Mediated Systemic Adverse Drug Reactions in a Drug-Drug Interaction Study of Dolutegravir With Once-Weekly Isoniazid and Rifapentine.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018Trial
- Daily rifapentine for treatment of pulmonary tuberculosis. A randomized, dose-ranging trial.American journal of respiratory and critical care medicine · 2015Trial
- Pharmacokinetics of Rifapentine and Desacetyl Rifapentine in Maternal Plasma and Breast Milk & Infant Cord Blood and Plasma: A Model-Based Analysis of Mother-Infant Pairs for Tuberculosis Prevention.Clinical pharmacology and therapeutics · 2026Article
- A Validated LC-MS/MS Method for Unbound Rifapentine Quantitation Reveals Nonlinear Plasma Protein Binding and Comparable Free Fractions Between Adults and Children with Tuberculosis.European journal of drug metabolism and pharmacokinetics · 2026Article
- Dolutegravir concentrations in children receiving 3-month weekly isoniazid and rifapentine (3HP) for tuberculosis prevention.Microbiology spectrum · 2026Observational
- Unexpected Clinical Drug-Drug Interaction of Fexinidazole on Midazolam Pharmacokinetics: Insights into Underlying Mechanisms from Clinical Phase I Study Results and Supporting In Vivo/Vitro Evidence.Clinical drug investigation · 2026Article
- New drugs for the management of tuberculosis.Current opinion in infectious diseases · 2025Review
- Development and hepatotoxicity of rifamycin derivatives.Expert opinion on drug metabolism & toxicology · 2025Review
- Therapeutic drug monitoring in tuberculosis.European journal of clinical pharmacology · 2024Review
- An Overview of Various Rifampicin Analogs againstMedicinal chemistry (Shariqah (United Arab Emirates)) · 2024Review
- Translational predictions of phase 2a first-in-patient efficacy studies for antituberculosis drugs.The European respiratory journal · 2023Article
- Optimizing (O) rifapentine-based (RI) regimen and shortening (EN) the treatment of drug-susceptible tuberculosis (T) (ORIENT) using an adaptive seamless design: study protocol of a multicenter randomized controlled trial.BMC infectious diseases · 2023Article
- Effect of a modified regimen on drug-sensitive retreated pulmonary tuberculosis: A multicenter study in China.Frontiers in public health · 2023Article
- New and Repurposed Drugs for the Treatment of Active Tuberculosis: An Update for Clinicians.Respiration; international review of thoracic diseases · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 5 institutions in 1 country.
Funding
Abstract
Rifapentine (RP T) is an antituberculosis drug that may shorten treatment duration when substituted for rifampin (RI F).The maximal tolerated daily dose of RP T and its potential for cytochrome 3A4 induction and autoinduction at clinically relevant doses are unknown. In this phase I, dose-escalation study among healthy volunteers, daily doses as high asa prespecified maximum of 20 mg/kg/day were well tolerated. Steady-state RP T concentrations increased with dose from 5 to 15 mg/kg, but area under the plasma concentration–time curve (AU C0–24) and maximum concentration (Cmax)were similar in the 15- and 20-mg/kg cohorts. Although RP T pharmacokinetics (PK) appeared to be time-dependent,accumulation occurred with daily dosing. The mean AU C0–12 of oral midazolam (MDZ), a cytochrome 3A (CYP 3A) probe drug, was reduced by 93% with the coadministration of RPT and by 74% with the coadministration of RIF (P < 0.01).Changes in the oral clearance of MDZ did not vary by RP T dose. In conclusion, RP T was tolerated at doses as high as20 mg/kg/day, its PK were less than dose-proportional, and its CYP 3A induction was robust.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.