Evidence map›Paper›PMID 30060248›Full record

Trial reportToxicological sciences : an official journal of the Society of Toxicology2018

Using Quantitative Systems Toxicology to Investigate Observed Species Differences in CKA-Mediated Hepatotoxicity.

Christina Battista, Kyunghee Yang, Simone H Stahl, Jerome T Mettetal, Paul B Watkins, Scott Q Siler, Brett A Howell

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Toxicological sciences : an official journal of the Society of Toxicology, 2018. 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. Review
  4. 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

7 authors.

Christina BattistaDILIsym Services, Inc., Research Triangle Park, North Carolina.
Kyunghee YangDILIsym Services, Inc., Research Triangle Park, North Carolina.
Simone H StahlSafety and ADME Translational Sciences, Drug Safety and Metabolism, IMED Biotech Unit, Astra Zeneca R&D, Cambridge CB4 0WG, UK.
Jerome T MettetalSafety and ADME Translational Sciences, Drug Safety and Metabolism, IMED Biotech Unit, Astra Zeneca R&D, Waltham, Massachusetts.
Paul B WatkinsDivision of Pharmacotherapy and Experimental Therapeutics, UNC Institute for Drug Safety Sciences, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
Scott Q SilerDILIsym Services, Inc., Research Triangle Park, North Carolina.
Brett A HowellDILIsym Services, Inc., Research Triangle Park, North Carolina.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

CKA, a chemokine receptor antagonist intended for treating inflammatory conditions, produced dose-dependent hepatotoxicity in rats but advanced into the clinic where single doses of CKA up to 600 mg appeared safe in humans. Because existing toxicological platforms used during drug development are not perfectly predictive, a quantitative systems toxicology model investigated the hepatotoxic potential of CKA in humans and rats through in vitro assessments of CKA on mitochondrial respiration, oxidative stress, and bile acid transporters. DILIsym predicted that single doses of CKA caused serum ALT >3xULN in a subset of the simulated rat population, while single doses in a simulated human population did not produce serum ALT elevations. Species differences were largely attributed to differences in liver exposure, but increased sensitivity to inhibition of mitochondrial respiration in the rat also contributed. We conclude that mechanistic modeling can elucidate species differences in the hepatotoxic potential of drug candidates.

Indexed as

Models, BiologicalAdultAnimalsCarboxylic AcidsCarrier ProteinsChemical and Drug Induced Liver InjuryDose-Response Relationship, DrugDouble-Blind MethodFemaleHep G2 CellsHumansIndolesLiver Function TestsMaleMembrane GlycoproteinsMiddle Aged1-(4-chloro-3-trifluoromethyl-benzyl)-5-hydroxy-1-H-indole-2-carboxylic acidbile acid binding proteinsCarboxylic AcidsCarrier ProteinsIndolesMembrane GlycoproteinsReceptors, Chemokine

Identifiers

PMID30060248
PMCPMC6204762

What OpenQuestion holds

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LicenceCC BY-NC
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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.