Evidence map›Paper›PMID 29752643›Full record

ArticleEuropean journal of drug metabolism and pharmacokinetics2018

Effect of Multiple Doses of Omeprazole on the Pharmacokinetics, Safety, and Tolerability of Roxadustat in Healthy Subjects.

Dorien Groenendaal-van de Meent, Martin den Adel, Jan van Dijk, Begona Barroso-Fernandez, Rachid El Galta, Georg Golor, Marloes Schaddelee

Open access · hybridAbstract readClinical Trial, Phase I
In one paragraph

Article in European journal of drug metabolism and pharmacokinetics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
2.1field-weighted citation impact, top 13% 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

12 citing papers in PubMed, 23 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Review
  6. Roxadustat: Not just for anemia.Frontiers in pharmacology · 2022
    Review
  7. Review
  8. Article
  9. Article
  10. Article
  11. Review
  12. 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 at 1 institution in 1 country.

Dorien Groenendaal-van de MeentClinical Pharmacology and Exploratory Development, Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE, Leiden, The Netherlands. Dorien.Groenendaal@astellas.com.
Martin den AdelClinical Pharmacology and Exploratory Development, Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE, Leiden, The Netherlands.
Jan van DijkClinical Pharmacology and Exploratory Development, Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE, Leiden, The Netherlands.
Begona Barroso-FernandezDrug Discovery Research/Bioanalysis Europe, Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE, Leiden, The Netherlands.
Rachid El GaltaData Science Biostatistics, Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE, Leiden, The Netherlands.
Georg GolorPAREXEL, Spandauer Damm 130, 14050, Berlin, Germany.
Marloes SchaddeleeBusiness Development, Transaction Execution Group, Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE, Leiden, The Netherlands.
Astellas Pharma (Netherlands) · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesRoxadustat is an orally active hypoxia-inducible factor prolyl hydroxylase inhibitor for the treatment of anemia in chronic kidney disease. This study investigated the effect of multiple daily oral doses of omeprazole on the pharmacokinetics, safety, and tolerability of a single oral dose of roxadustat.

methodsThis phase 1, open-label, two-period, one-sequence, crossover study enrolled healthy subjects. During Period 1, subjects received a single oral dose of 100 mg roxadustat. After a ≥ 7-day washout, subjects started Period 2 and received daily oral doses of 40 mg omeprazole on Days 1-9, and a single oral dose of 100 mg roxadustat on Day 7. Roxadustat pharmacokinetics were assessed on Days 1-4 in Period 1 and on Days 7-10 in Period 2. Primary endpoints were area under the concentration-time profile from the time of dosing extrapolated to infinity (AUC

resultsEighteen subjects were enrolled. The geometric least squares mean ratio for both AUC

conclusionMultiple daily oral doses of 40 mg omeprazole had no significant effect on the pharmacokinetics of a single oral dose of 100 mg roxadustat. Roxadustat was considered safe and well tolerated when administered alone or in combination with multiple daily oral doses of 40 mg omeprazole in healthy subjects.

Indexed as

Administration, OralAdultArea Under CurveCross-Over StudiesDrug InteractionsFemaleGlycineHumansHypoxia-Inducible Factor-Proline DioxygenasesIsoquinolinesMaleMiddle AgedOmeprazoleProton Pump InhibitorsGlycineHypoxia-Inducible Factor-Proline DioxygenasesIsoquinolinesOmeprazoleProton Pump Inhibitorsroxadustat

Identifiers

PMID29752643
PMCPMC6244714
OpenAlexW2800023931

What OpenQuestion holds

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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.