Evidence map›Paper›PMID 30194585›Full record

ArticleClinical drug investigation2018

Pharmacokinetics and Safety After a Single Dose of Imarikiren in Subjects with Renal or Hepatic Impairment.

Yukio Shimasaki, Masashi Sakaki, Minoru Itou, Tokurou Kobayashi, Masako Aso, Tomoya Kagawa, Takuya Saiki, Kumi Matsuno, Yuhei Sano, Kohei Shimizu and 2 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in Clinical drug investigation, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02367872 (Phase I Open-label, Parallel-group, Comparative Study to Evaluate the Effects of Renal or Hepatic Impairment on TAK-272 Pharmacokinetics With a Single Oral Administration of TAK-272 in Patients With Renal or Hepatic Impairment), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact, top 80% 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.

NCT02367872 phase1completednot on this map

Phase I Open-label, Parallel-group, Comparative Study to Evaluate the Effects of Renal or Hepatic Impairment on TAK-272 Pharmacokinetics With a Single Oral Administration of TAK-272 in Patients With Renal or Hepatic Impairment

TypeinterventionalSponsorTakedaRan2015 to 2016Enrolled48ConditionsRenal Impairment, Hepatic ImpairmentArmsTAK-272
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

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

12 authors at 5 institutions in 1 country.

Yukio ShimasakiTakeda Pharmaceutical Company Ltd., Tokyo, Japan. yukio.shimasaki@takeda.com.
Masashi SakakiDivision of Gastroenterology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.
Minoru ItouDivision of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Fukuoka, Japan.
Tokurou KobayashiMoriya Keiyu Hospital, Ibaraki, Japan.
Masako AsoKitasato University Hospital, Kanagawa, Japan.
Tomoya KagawaSCOHIA PHARMA, Inc., Kanagawa, Japan.
Takuya SaikiSCOHIA PHARMA, Inc., Kanagawa, Japan.
Kumi MatsunoTakeda Pharmaceutical Company Ltd., Osaka, Japan.
Yuhei SanoTakeda Pharmaceutical Company Ltd., Osaka, Japan.
Kohei ShimizuTakeda Pharmaceutical Company Ltd., Osaka, Japan.
Shingo KurodaTakeda Pharmaceutical Company Ltd., Osaka, Japan.
Emiko KoumuraTakeda Pharmaceutical Company Ltd., Osaka, Japan.
Takeda (Japan) · JPkeiyu Hospital · JPKitasato University Hospital · JPKurume University · JPShowa University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveImarikiren hydrochloride (TAK-272; SCO-272) is a novel direct renin inhibitor. The objective of this study was to determine the effects of renal impairment (RI) or hepatic impairment (HI) on the pharmacokinetics and safety of imarikiren.

methodsThis phase I, open-label, parallel-group comparative study evaluated the pharmacokinetics and safety of a single 40 mg oral dose of imarikiren in RI [mild, moderate, severe, or end-stage renal disease (ESRD), and on hemodialysis] or HI (mild or moderate) subjects compared with subjects with normal renal or hepatic function.

resultsFollowing administration of a single 40 mg oral imarikiren dose, the geometric mean imarikiren area under the plasma concentration-time curve from time zero to infinity (AUC

conclusionsRI and HI are associated with limited changes in imarikiren pharmacokinetics. Imarikiren was safe and well-tolerated, regardless of the severity of RI or HI. CLINICAL

trial registrationClinicalTrials.gov Identifier: NCT02367872.

Indexed as

AdultAgedArea Under CurveBenzimidazolesCardiovascular AgentsEnzyme InhibitorsFemaleHumansKidneyKidney Failure, ChronicLiver DiseasesMaleMiddle AgedMorpholinesPiperidinesRenal DialysisBenzimidazolesCardiovascular AgentsEnzyme Inhibitorsimarikiren hydrochlorideMorpholinesPiperidines

Identifiers

PMID30194585
OpenAlexW2892273974

What OpenQuestion holds

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Registered trials

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.