Evidence map›Paper›PMID 27169903›Full record

ArticleClinical and translational science2016

Pharmacokinetics, Safety, and CCR2/CCR5 Antagonist Activity of Cenicriviroc in Participants With Mild or Moderate Hepatic Impairment.

E Lefebvre, M Gottwald, K Lasseter, W Chang, M Willett, P F Smith, A Somasunderam, N S Utay

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in Clinical and translational science, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02217475 (CENTAUR), which is not on this map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
4.7field-weighted citation impact, top 4% 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.

NCT02217475 phase2completednot on this map

CENTAUR: Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Subjects With Liver Fibrosis

TypeinterventionalSponsorTobira Therapeutics, Inc.Ran2014 to 2017Enrolled289ConditionsNonalcoholic SteatohepatitisArmsCenicriviroc, Placebo
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 52 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Review
  5. Review
  6. Article
  7. Review
  8. New Drugs for Hepatic Fibrosis.Frontiers in pharmacology · 2022
    Review
  9. Review
  10. Review
  11. Review
  12. Article
  13. Review
  14. Review
  15. Review
  16. Review
  17. Article
  18. Liver sinusoidal endothelial cells - gatekeepers of hepatic immunity.Nature reviews. Gastroenterology & hepatology · 2018
    Review
  19. 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

8 authors at 6 institutions in 1 country.

E LefebvreTobira Therapeutics, Inc., South San Francisco, California, USA.
M GottwaldTobira Therapeutics, Inc., South San Francisco, California, USA.
K LasseterClinical Pharmacology of Miami, Inc., Miami, Florida, USA.
W ChangTobira Therapeutics, Inc., South San Francisco, California, USA.
M WillettReady Clinical, LLC, Princeton, New Jersey, USA.
P F Smithd3 Medicine, LLC, Parsippany, New Jersey, USA.
A SomasunderamUniversity of Texas Medical Branch at Galveston, Galveston, Texas, USA.
N S UtayUniversity of Texas Medical Branch at Galveston, Galveston, Texas, USA.
Nkarta Therapeutics (United States) · USThe University of Texas Medical Branch at Galveston · USClinical Pharmacology of Miami · USLearning Ally · USRapt Therapeutics (United States) · USReckitt Benckiser (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Cenicriviroc, a dual CCR2/CCR5 antagonist, is being evaluated for treatment of nonalcoholic steatohepatitis and liver fibrosis (CENTAUR; NCT02217475). As it is metabolized by the liver, cenicriviroc was investigated in hepatic-impaired participants for pharmacokinetic changes. Participants with mild-to-moderate hepatic impairment (HI) (Child-Pugh class A (N  =  7) or B (N = 8)) and matched controls (N = 15) received cenicriviroc 150 mg once daily for 14 days. Serial blood samples were obtained on Days 1 and 14. Safety, tolerability, and effects on CCR2/CCR5 ligands, cytokines, and bacterial translocation biomarkers were evaluated. Cenicriviroc exposures were increased by moderate HI (AUC0-τ  55%, Cmax 29% higher) but were not with mild HI (AUC0-τ 38%, Cmax 40% lower). Cenicriviroc was well tolerated. Rapid and potent CCR2/CCR5 blockade was observed, not associated with increases in hepatic inflammation or bacterial translocation biomarkers. Study findings suggest that cenicriviroc 150 mg can be used in patients with mild-to-moderate HI.

Indexed as

Bacterial TranslocationBiomarkersCase-Control StudiesCytokinesDemographyFatty Acid-Binding ProteinsFemaleFlagellinHumansImidazolesInflammation MediatorsIntestinesLiver DiseasesMaleMiddle AgedPermeabilityBiomarkerscenicrivirocCytokinesFatty Acid-Binding ProteinsFlagellinImidazolesInflammation MediatorsReceptors, CCR2Receptors, CCR5Sulfoxides

Identifiers

PMID27169903
PMCPMC5351328
OpenAlexW2388847993

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.