Evidence map›Paper›PMID 27552251›Full record

Trial reportBritish journal of clinical pharmacology2017

Use of a cocktail probe to assess potential drug interactions with cytochrome P450 after administration of belatacept, a costimulatory immunomodulator.

Daphne Williams, Xiaolu Tao, Lili Zhu, Michele Stonier, Justin D Lutz, Eric Masson, Sean Zhang, Bishu Ganguly, Zoe Tzogas, Susan Lubin and 1 more

Open access · hybridAbstract readClinical Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.4field-weighted citation impact, top 16% 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

8 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Evidence-based complementary and alternative medicine : eCAM · 2019
    Article
  7. Article
  8. 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

11 authors at 3 institutions in 4 countries.

Daphne WilliamsBristol-Myers Squibb Research and Development, Pennington, New Jersey, USA.
Xiaolu TaoBristol-Myers Squibb Research and Development, Pennington, New Jersey, USA.
Lili ZhuBristol-Myers Squibb Research and Development, Pennington, New Jersey, USA.
Michele StonierBristol-Myers Squibb Research and Development, Pennington, New Jersey, USA.
Justin D LutzBristol-Myers Squibb Research and Development, Pennington, New Jersey, USA.
Eric MassonBristol-Myers Squibb Research and Development, Pennington, New Jersey, USA.
Sean ZhangBristol-Myers Squibb Research and Development, Pennington, New Jersey, USA.
Bishu GangulyBristol-Myers Squibb Research and Development, Pennington, New Jersey, USA.
Zoe TzogasBristol-Myers Squibb Research and Development, Pennington, New Jersey, USA.
Susan LubinBristol-Myers Squibb Research and Development, Pennington, New Jersey, USA.
Bindu MurthyBristol-Myers Squibb Research and Development, Pennington, New Jersey, USA.
Bristol-Myers Squibb (Germany) · DEBristol-Myers Squibb (United States) · USGlaxoSmithKline (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimThis open-label study investigated the effect of belatacept on cytokine levels and on the pharmacokinetics of caffeine, losartan, omeprazole, dextromethorphan and midazolam, as CYP probe substrates after oral administration of the Inje cocktail in healthy volunteers.

methodsTwenty-two evaluable subjects received the Inje cocktail on Days 1, 4, 7 and 11 and belatacept infusion on Day 4.

resultsSince belatacept caused no major alterations to cytokine levels, there were no major effects on CYP-substrate pharmacokinetics, except for a slight (16-30%) increase in omeprazole exposure, which was probably due to omeprazole-mediated, time-dependent CYP inhibition. Belatacept did not cause major alterations in the pharmacokinetics, as measured by the geometric mean ratios and associated 90% confidence interval for area under the plasma concentration -time curve from time zero to infinity on Day 7 comparing administration with and without belatacept for caffeine (1.002 [0.914, 1.098]), dextromethorphan (1.031 [0.885, 1.200]), losartan (1.016 [0.938, 1.101)], midazolam (0.968 [0.892, 1.049]) or their respective metabolites.

conclusionsTherefore, no dose adjustments of CYP substrates are indicated with belatacept coadministration.

Indexed as

AbataceptAdultArea Under CurveCytochrome P-450 Enzyme SystemCytokinesDrug InteractionsFemaleHumansImmunosuppressive AgentsMalePharmacokineticsTime FactorsYoung AdultAbataceptCytochrome P-450 Enzyme SystemCytokinesImmunosuppressive AgentsBiologicscytochrome P450interactionpharmacokineticstransplantation

Identifiers

PMID27552251
PMCPMC5237687
OpenAlexW2513360290

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.