Evidence map›Paper›PMID 19884374›Full record

Trial reportAntimicrobial agents and chemotherapy2010

Multiple-dose safety, tolerability, and pharmacokinetics of oral nemonoxacin (TG-873870) in healthy volunteers.

David T Chung, Cheng-Yuan Tsai, Shu-Jen Chen, Li-Wen Chang, Chi-Hsin R King, Ching-Hung Hsu, Kit-Mui Chiu, Hao-Chen Tan, Yu-Ting Chang, Ming-Chu Hsu

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 15% of its field
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

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 42 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Review
  9. Article
  10. Review
  11. Article
  12. Frontiers in microbiology · 2019
    Article
  13. Article
  14. Review
  15. Article
  16. Review
  17. Article
  18. Review of nemonoxacin with special focus on clinical development.Drug design, development and therapy · 2014
    Review
  19. Pipeline of Known Chemical Classes of Antibiotics.Antibiotics (Basel, Switzerland) · 2013
    Review
  20. Article
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

10 authors at 1 institution in 1 country.

David T ChungTaiGen Biotechnology Co. Ltd., 7F, 138 Xing Ming Road, Neihu District, 11470 Taipei, Taiwan. davidchung@taigenbiotech.com
Cheng-Yuan Tsai
Shu-Jen Chen
Li-Wen Chang
Chi-Hsin R King
Ching-Hung Hsu
Kit-Mui Chiu
Hao-Chen Tan
Yu-Ting Chang
Ming-Chu Hsu
TaiGen Biotechnology (Taiwan) · TW

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Nemonoxacin (TG-873870) is a novel nonfluorinated quinolone with broad-spectrum activities against Gram-positive and Gram-negative aerobic, anaerobic, and atypical pathogens, as well as against methicillin-resistant Staphylococcus aureus, vancomycin-resistant S. aureus, and multiple-resistant bacterial pathogens. We conducted a randomized, double-blind, placebo-controlled, dose-escalating study to ascertain the safety, tolerability, and pharmacokinetics of nemonoxacin. We enrolled 46 healthy volunteers and used a once-daily oral-dosing range of 75 to 1,000 mg for 10 days. Additionally, the food effect was evaluated in subjects in the 500-mg cohort. Nemonoxacin was generally safe and well tolerated, with no significant changes in the clinical laboratory tests or electrocardiograms. Adverse effects, including headache, contact dermatitis, and rash, were mild and resolved spontaneously. Nemonoxacin was rapidly absorbed within 2 h postdosing, and generally, a steady state was reached after 3 days. The maximum plasma concentration and the area under the plasma concentration-time curve were dose proportional over the dosing range. The elimination half-life was approximately 7.5 h and 19.7 h on days 1 and 10, respectively. Approximately 37 to 58% of the drug was excreted in the urine. Food affected the pharmacokinetics, with decreases in the maximum plasma concentration and area under the plasma concentration-time curve of 46% and 27%, respectively. However, the free AUC/MIC(90) of nemonoxacin was more than 100 under both the fasting and fed conditions, predicting the efficacy of nemonoxacin against most of the tested pathogens. In conclusion, the results support further clinical investigation of once-daily nemonoxacin administration for antibiotic-sensitive and antibiotic-resistant bacterial infections.

Indexed as

AdolescentAdultAnti-Bacterial AgentsDermatitis, ContactDose-Response Relationship, DrugDouble-Blind MethodElectrocardiographyEnzymesFemaleHeadacheHumansMaleQuinolonesYoung AdultAnti-Bacterial AgentsEnzymesnemonoxacinQuinolones

Identifiers

PMID19884374
PMCPMC2798523
OpenAlexW2135701861

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.