Evidence map›Paper›PMID 31410633›Full record

Trial reportJournal of pharmacokinetics and pharmacodynamics2019

Concentration-response modeling of ECG data from early-phase clinical studies to assess QT prolongation risk of contezolid (MRX-I), an oxazolidinone antibacterial agent.

Junzhen Wu, Kun Wang, Yuancheng Chen, Hong Yuan, Li Li, Jing Zhang

Abstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of pharmacokinetics and pharmacodynamics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Observational
  4. Novel oxazolidinones harbor potentFrontiers in medicine · 2022
    Article
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Junzhen WuInstitute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.
Kun WangCertara Strategic Consulting China, Shanghai, 200122, China.
Yuancheng ChenInstitute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.
Hong YuanInstitute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.
Li LiInstitute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.
Jing ZhangInstitute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China. zhangj_fudan@aliyun.com.ORCID 0000-0003-2966-9149

Funding

The Major Research and Development Project of Innovative Drugs, Ministry of Science and Technology of China 2017ZX09304005
6 · The paper itself

Abstract

The effects of contezolid (MRX-I, an oxazolidinone antibacterial agent) on cardiac repolarization were evaluated retrospectively using a population modeling approach in a Phase I study incorporating single ascending dose, multiple ascending dose, and food effect assessments. Linear mixed effect models were used to assess the relationships between MRX-I plasma concentrations and QT/QTc/∆QTc (baseline-adjusted), in which different correction methods for heart rate have been included. The upper bound of the one-sided 95% confidence interval (CI) for predicted ∆∆QTc was < 10 ms (ms) at therapeutic doses of MRX-I. Model performance/suitability was determined using diagnostic evaluations, which indicated rationality of one-stage concentration-QT model, as well as C-QT model suggested by Garnett et al. The finding demonstrated that MRX-I may have no clinical effects on the QT interval. Concentration-QT model may be an alternative to conventional thorough QT studies.

Indexed as

AdultAnti-Bacterial AgentsCross-Over StudiesDouble-Blind MethodElectrocardiographyFemaleHeart RateHumansLinear ModelsMaleOxazolidinonesPyridonesRetrospective StudiesRiskAnti-Bacterial AgentscontezolidOxazolidinonesPyridonesC-QT modelMRX-IPopulation pharmacodynamicsQT interval

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.