Evidence map›Paper›PMID 28639119›Full record

Trial reportEuropean journal of clinical pharmacology2017

A pharmacokinetic drug-drug interaction study between selexipag and midazolam, a CYP3A4 substrate, in healthy male subjects.

Pierre-Eric Juif, Margaux Boehler, Yves Donazzolo, Shirin Bruderer, Jasper Dingemanse

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European 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 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
3.3field-weighted citation impact, top 9% 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

7 citing papers in PubMed, 18 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

5 authors at 2 institutions in 2 countries.

Pierre-Eric JuifDepartment of Clinical Pharmacology, Actelion Pharmaceuticals Ltd., Gewerbestrasse 16, 4123, Allschwil, Switzerland. pierre-eric.juif@actelion.com.
Margaux BoehlerDepartment of Clinical Pharmacology, Actelion Pharmaceuticals Ltd., Gewerbestrasse 16, 4123, Allschwil, Switzerland.
Yves DonazzoloEurofins Optimed, 1 rue des Essarts, 38610, Gieres, France.
Shirin BrudererDepartment of Clinical Pharmacology, Actelion Pharmaceuticals Ltd., Gewerbestrasse 16, 4123, Allschwil, Switzerland.
Jasper DingemanseDepartment of Clinical Pharmacology, Actelion Pharmaceuticals Ltd., Gewerbestrasse 16, 4123, Allschwil, Switzerland.
Actelion (Switzerland) · CHEurofins (France) · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeIn vitro data showed that selexipag and its active metabolite (ACT-333679) have an inductive effect on CYP3A4, CYP2B6, and CYP2C9 at concentrations approximately 100-fold higher than the maximum plasma concentration (C

methodsThis study was conducted according to an open-label, randomized, two-way crossover design. A total of 20 subjects received a single oral dose of 7.5 mg midazolam alone (treatment A) or on top of steady-state selexipag (treatment B). Selexipag was administered twice daily using an up-titration scheme consisting of three steps: 400, 600, 1000, and 1600 μg with increments every fourth day. A 24-h pharmacokinetic profile was performed following midazolam administration, and bioequivalence criteria were investigated on an exploratory basis.

resultsThe C

conclusionExposure to midazolam and 1-hydroxymidazolam was not affected by treatment with selexipag.

Indexed as

AcetamidesAdultAntihypertensive AgentsArea Under CurveCross-Over StudiesCytochrome P-450 CYP3ADrug InteractionsHalf-LifeHealthy VolunteersHumansMaleMidazolamPyrazinesYoung AdultAcetamidesAntihypertensive AgentsCYP3A4 protein, humanCytochrome P-450 CYP3AMidazolamPyrazinesselexipagCYP3A4Drug interactionsMidazolamPharmacokineticsSelexipag

Identifiers

PMID28639119
OpenAlexW2682249395

What Socratic holds

Textmetadata
Read underepoch 390

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 Socratic graph.