Evidence map›Paper›PMID 32248614›Full record

ArticleBasic & clinical pharmacology & toxicology2020

Absorption, distribution, metabolism and excretion of molidustat in healthy participants.

Silvia Lentini, Dorina van der Mey, Armin Kern, Uwe Thuss, Andreas Kaiser, Kumi Matsuno, Michael Gerisch

Open access · bronzeAbstract read
In one paragraph

Article in Basic & clinical pharmacology & toxicology, 2020. 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
1.0field-weighted citation impact, top 22% 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, 12 citations in OpenAlex.

  1. Review
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  7. Metabolite Profiling of Meridianin C In Vivo of Rat by UHPLC/Q-TOF MS.Journal of analytical methods in chemistry · 2021
    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

7 authors at 2 institutions in 2 countries.

Silvia LentiniClinical Pharmacology Cardiovascular/Haematology, Translational Sciences, Research & Development, Bayer AG, Wuppertal, Germany.ORCID https://orcid.org/0000-0001-9987-8814
Dorina van der MeyClinical Pharmacology Cardiovascular/Haematology, Translational Sciences, Research & Development, Bayer AG, Wuppertal, Germany.ORCID https://orcid.org/0000-0003-2779-9388
Armin KernDrug Metabolism and Pharmacokinetics, Research & Development, Bayer AG, Wuppertal, Germany.
Uwe ThussDrug Metabolism and Pharmacokinetics, Research & Development, Bayer AG, Wuppertal, Germany.
Andreas KaiserStatistics and Data Insights, Data Sciences & Analytics, Research & Development, Bayer AG, Berlin, Germany.
Kumi MatsunoClinical Sciences, Research and Development Japan, Bayer Yakuhin Ltd, Osaka, Japan.
Michael GerischDrug Metabolism and Pharmacokinetics, Research & Development, Bayer AG, Wuppertal, Germany.
Bayer (Germany) · DEBayer (Japan) · JP

Funding

Bayer Yakuhin Ltd
6 · The paper itself

Abstract

The absorption, distribution, metabolism and excretion of molidustat were investigated in healthy male participants. In study 1, a mass balance study, radiolabelled molidustat 25 mg (3.57 MBq) was administered as an oral solution (n = 4). Following rapid absorption, molidustat-related radioactivity was predominantly distributed in plasma rather than in red blood cells. The total recovery of the administered radioactivity was 97.0%, which was mainly excreted renally (90.7%). Metabolite M-1, produced by N-glucuronidation, was the dominant component in plasma (80.2% of the area under the concentration-time curve for total radioactivity) and was primarily excreted via urine (~85% of dose). Only minor amounts of unchanged molidustat were excreted in urine (~4%) and faeces (~6%). Study 2 investigated the absolute bioavailability and pharmacodynamics of molidustat (part 1, n = 12; part 2, n = 16). Orally administered molidustat immediate release tablets had an absolute bioavailability of 59%. Following intravenous administration (1, 5 and 25 mg), total body clearance of molidustat was 28.7-34.5 L/h and volume of distribution at steady state was 39.3-50.0 L. All doses of molidustat transiently elevated endogenous erythropoietin levels, irrespective of the route of administration. Molidustat was considered safe and well tolerated at the administered doses.

Indexed as

Administration, OralAdultBiological AvailabilityDrug Evaluation, PreclinicalHealthy VolunteersHumansInfusions, IntravenousMaleMetabolic Clearance RateMiddle AgedPyrazolesTissue DistributionTriazolesmolidustatPyrazolesTriazolesADME (absorptionbiotransformationdispositionerythropoietinexcretion)metabolism

Identifiers

PMID32248614
PMCPMC7496954
OpenAlexW3014584408

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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 OpenQuestion graph.