Evidence map›Paper›PMID 30105453›Full record

ArticleEuropean journal of clinical pharmacology2018

Siponimod pharmacokinetics, safety, and tolerability in combination with rifampin, a CYP2C9/3A4 inducer, in healthy subjects.

Anne Gardin, Cathy Gray, Srikanth Neelakantham, Felix Huth, Antonia M Davidson, Swati Dumitras, Eric Legangneux, Kasra Shakeri-Nejad

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Article in European journal of clinical pharmacology, 2018. 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
0.8field-weighted citation impact, top 27% 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, 14 citations in OpenAlex.

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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 5 institutions in 3 countries.

Anne GardinNovartis Institutes for BioMedical Research, Basel, Switzerland. anne.gardin@novartis.com.
Cathy GrayNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Srikanth NeelakanthamNovartis Healthcare Pvt. Ltd., Hyderabad, India.
Felix HuthNovartis Institutes for BioMedical Research, Basel, Switzerland.
Antonia M DavidsonPPD, Austin, TX, USA.
Swati DumitrasNovartis Institutes for BioMedical Research, Basel, Switzerland.
Eric LegangneuxNovartis Institutes for BioMedical Research, Basel, Switzerland.
Kasra Shakeri-NejadNovartis Institutes for BioMedical Research, Basel, Switzerland.
Novartis (Switzerland) · CHNovartis (India) · INNovartis Institutes for BioMedical ResearchNovartis (United States) · USPharmaceutical Product Development (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo assess the potential pharmacokinetic (PK) interactions between siponimod and rifampin, a strong CYP3A4/moderate CYP2C9 inducer, in healthy subjects.

methodsThis was a confirmatory, open-label, multiple-dose two-period study in healthy subjects (aged 18-45 years). In Period 1 (Days 1-12), siponimod was up-titrated from 0.25 to 2 mg over 5 days (Days 1-6) followed by 2 mg once daily on days 7-12. In Period 2, siponimod 2 mg qd was co-administered with rifampin 600 mg qd (Days 13-24). Primary assessments included PK of siponimod (Days 12 and 24; maximum steady-state plasma concentration [C

resultsOf the 16 subjects enrolled (age, mean ± standard deviation [SD] 31 ± 8.3 years; men, n = 15), 15 completed the study. In Period 1, siponimod geometric mean C

conclusionsThe study findings suggest that in the presence of rifampin, a strong CYP3A4/moderate CYP2C9 inducer, siponimod showed significant decrease in C

Indexed as

AdolescentAdultArea Under CurveAzetidinesBenzyl CompoundsBiotransformationCytochrome P-450 CYP2C9Drug InteractionsEnzyme InductionFemaleHealthy VolunteersHumansLymphocyte CountMaleReceptors, LysosphingolipidRifampinAzetidinesBenzyl CompoundsCYP2C9 protein, humanCytochrome P-450 CYP2C9Receptors, LysosphingolipidRifampinsiponimodDrug–drug interactionsHealthy subjectsPharmacokineticsRifampinSiponimod

Identifiers

PMID30105453
OpenAlexW2885286902

What OpenQuestion holds

Textmetadata
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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.