Evidence map›Paper›PMID 31182528›Full record

Trial reportAntimicrobial agents and chemotherapy2019

First-Time-in-Human Study and Prediction of Early Bactericidal Activity for GSK3036656, a Potent Leucyl-tRNA Synthetase Inhibitor for Tuberculosis Treatment.

David Tenero, Geo Derimanov, Alex Carlton, John Tonkyn, Matt Davies, Simon Cozens, Stephanie Gresham, Alison Gaudion, Adeep Puri, Morris Muliaditan and 4 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06114628 (A Seamless Phase 2B/C Platform Trial to Evaluate Multiple Regimens and Durations of Treatment in Pulmonary Tuberculosis), which is not on this map. Cited by 33 papers.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed
5.3field-weighted citation impact, top 3% 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.

NCT06114628 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

A Seamless Phase 2B/C Platform Trial to Evaluate Multiple Regimens and Durations of Treatment in Pulmonary Tuberculosis

TypeinterventionalSponsorUniversity College, LondonRan2024 to 2027Enrolled2,500ConditionsPulmonary TuberculosisArmsGanfeborole, BTZ-043, Bedaquiline (B), Delamanid (D), Pretomanid (Pa)
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 71 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. REVOLUTIONIZING TUBERCULOSIS REGIMEN DEVELOPMENT.Transactions of the American Clinical and Climatological Association · 2025
    Review
  9. Article
  10. Review
  11. Article
  12. Article
  13. Review
  14. Beyond antibiotic resistance: thebioRxiv : the preprint server for biology · 2023
    Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  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

14 authors at 4 institutions in 3 countries.

David TeneroGlaxoSmithKline Clinical Pharmacology Modeling and Simulation, Collegeville, Pennsylvania, USA.
Geo DerimanovGlaxoSmithKline Clinical Pharmacology and Experimental Medicine, Collegeville, Pennsylvania, USA.
Alex CarltonGlaxoSmithKline Biostatistics, Stockley Park, London, United Kingdom.
John TonkynGlaxoSmithKline Global Sciences and Delivery, Stevenage, Hertfordshire, United Kingdom.
Matt DaviesGlaxoSmithKline Safety and Medical Governance, Stockley Park, London, United Kingdom.
Simon CozensGlaxoSmithKline, Translation Project Specialist Team, Ware, Hertfordshire, United Kingdom.
Stephanie GreshamGlaxoSmithKline, Mechanistic Safety and Disposition, Ware, Hertfordshire, United Kingdom.
Alison GaudionHammersmith Medicines Research, London, United Kingdom.
Adeep PuriHammersmith Medicines Research, London, United Kingdom.
Morris MuliaditanGlaxoSmithKline DMPK Modelling, Stevenage, Hertfordshire, United Kingdom.
Joaquin Rullas-TrincadoGlaxoSmithKline Global Health, TBDPU, Tres Cantos, Madrid, Spain.
Alfonso Mendoza-LosanaGlaxoSmithKline Global Health, TBDPU, Tres Cantos, Madrid, Spain.
Andrew SkingsleyGlaxoSmithKline Global Health Clinical Drug Development, Stockley Park, London, United Kingdom.
David Barros-AguirreGlaxoSmithKline Global Health, TBDPU, Tres Cantos, Madrid, Spain david.a.barros@gsk.com.ORCID 0000-0002-4099-0438
GlaxoSmithKline (United Kingdom) · GBGlaxoSmithKline (Spain) · ESGlaxoSmithKline (United States) · USHammersmith Medicines Research · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This first-time-in-human (FTIH) study evaluated the safety, tolerability, pharmacokinetics, and food effect of single and repeat oral doses of GSK3036656, a leucyl-tRNA synthetase inhibitor. In part A, GSK3036656 single doses of 5 mg (fed and fasted), 15 mg, and 25 mg and placebo were administered. In part B, repeat doses of 5 and 15 mg and placebo were administered for 14 days once daily. GSK3036656 showed dose-proportional increase following single-dose administration and after dosing for 14 days. The maximum concentration of drug in serum (

Indexed as

Administration, OralAdolescentAdultAntitubercular AgentsArea Under CurveBoron CompoundsDouble-Blind MethodEnzyme InhibitorsFemaleFoodHeterocyclic Compounds, 2-RingHumansLeucine-tRNA LigaseMaleMiddle AgedModels, BiologicalAntitubercular AgentsBoron CompoundsEnzyme InhibitorsGSK656Heterocyclic Compounds, 2-RingLeucine-tRNA LigasePlacebosclinical trial simulationsdose escalationdose rationaleEBA predictionfood effectFTIHGSK3036656pharmacokineticsrepeat dosesafetysingle dosetolerabilitytuberculosis

Identifiers

PMID31182528
PMCPMC6658769
OpenAlexW2946753625

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.