Trial reportBritish journal of clinical pharmacology2010
Levofloxacin can be used effectively as a positive control in thorough QT/QTc studies in healthy volunteers.
Trial report in British journal of clinical pharmacology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03827811 (Pharmacometrics to Advance Novel Regimens for Drug-resistant Tuberculosis), which is not on this map. Cited by 16 papers.
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.
Pharmacometrics to Advance Novel Regimens for Drug-resistant Tuberculosis
Who cites it
16 citing papers in PubMed, 34 citations in OpenAlex.
- Cardiac safety of bedaquiline, delamanid and moxifloxacin co-administered with or without varying doses of sutezolid or delpazolid for the treatment of drug-susceptible TB.The Journal of antimicrobial chemotherapy · 2025Trial
- Effects of the Fluoroquinolones Moxifloxacin and Levofloxacin on the QT Subintervals: Sex Differences in Ventricular Repolarization.Journal of clinical pharmacology · 2020Trial
- Insulin at normal physiological levels does not prolong QT(c) interval in thorough QT studies performed in healthy volunteers.British journal of clinical pharmacology · 2013Trial
- Repeated supratherapeutic dosing of strontium ranelate over 15 days does not prolong QT(c) interval in healthy volunteers.British journal of clinical pharmacology · 2012Trial
- Analysis of Respiratory Fluoroquinolones and the Risk of Sudden Cardiac Death Among Patients Receiving Hemodialysis.JAMA cardiology · 2022Article
- Adverse drug reactions in South African patients receiving bedaquiline-containing tuberculosis treatment: an evaluation of spontaneously reported cases.BMC infectious diseases · 2019Article
- Article
- Levofloxacin-Induced QTc Prolongation Depends on the Time of Drug Administration.CPT: pharmacometrics & systems pharmacology · 2016Article
- Prediction of the pharmacokinetics and tissue distribution of levofloxacin in humans based on an extrapolated PBPK model.European journal of drug metabolism and pharmacokinetics · 2016Article
- The Power of Phase I Studies to Detect Clinical Relevant QTc Prolongation: A Resampling Simulation Study.BioMed research international · 2015Article
- Drug-induced QT interval prolongation: does ethnicity of the thorough QT study population matter?British journal of clinical pharmacology · 2013Review
- Update on the cardiac safety of moxifloxacin.Current drug safety · 2012Article
- Comparison of the effects of levofloxacin on QT/QTc interval assessed in both healthy Japanese and Caucasian subjects (pages.British journal of clinical pharmacology · 2012Article
- Analysis of Relationship between Levofloxacin and Corrected QT Prolongation Using a Clinical Data Warehouse.Healthcare informatics research · 2011Article
- Editors' pick 2010.British journal of clinical pharmacology · 2011Article
- Novel targets and regulatory ordeal by QT interval.British journal of clinical pharmacology · 2010Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTo characterize the effects of levofloxacin on QT interval in healthy subjects and the most appropriate oral positive control treatments for International Conference on Harmonization (ICH) E14 QT/QTc studies.
methodsHealthy subjects received a single dose of levofloxacin (1000 or 1500 mg), moxifloxacin (400 mg) or placebo in a four-period crossover design. Digital 12-lead ECGs were recorded in triplicate. Measurement of QT interval was performed automatically with subsequent manual onscreen over-reading using electronic callipers. Blood samples were taken for determination of levofloxacin and moxifloxacin concentrations.
resultsMean QTcI (QT interval corrected for heart rate using a correction factor that is applicable to each individual) was prolonged in subjects receiving moxifloxacin 400 mg compared with placebo. The largest time-matched difference in QTcI for moxifloxacin compared with placebo was observed to be 13.19 ms (95% confidence interval 11.21, 15.17) at 3.5 h post dose. Prolonged mean QTcI was also observed in subjects receiving levofloxacin 1000 mg and 1500 mg compared with placebo. The largest time-matched difference in QTcI compared with placebo was observed at 3.5 h post dose for both 1000 mg and 1500 mg of levofloxacin [mean (95%) 4.42 ms (2.44, 6.39) in 1000 mg and 7.44 ms (5.47, 9.42) in 1500 mg]. A small increase in heart rate was observed with levofloxacin during the course of the study. However, moxifloxacin showed a greater increase compared with levofloxacin.
conclusionsBoth levofloxacin and moxifloxacin can fulfil the criteria for a positive comparator. The ICH E14 guidelines recommend a threshold of around 5 ms for a positive QT/QTc study. The largest time-matched difference in QTc for levofloxacin suggests the potential for use in more rigorous QT/QTc studies. This study has demonstrated the utility of levofloxacin on the assay in measuring mean QTc changes around 5 ms.
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