Evidence map›Paper›PMID 29134428›Full record

ArticleAdvances in therapy2017

The Influence of Hepatic and Renal Impairment on the Pharmacokinetics of a Treatment for Herpes Zoster, Amenamevir (ASP2151): Phase 1, Open-Label, Single-Dose, Parallel-Group Studies.

Tomohiro Kusawake, Donna Kowalski, Akitsugu Takada, Kota Kato, Masataka Katashima, James J Keirns, Michaelene Lewand, Kenneth C Lasseter, Thomas C Marbury, Richard A Preston

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

Article in Advances in therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed, 12 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

10 authors at 5 institutions in 2 countries.

Tomohiro KusawakeAstellas Pharma Global Development Inc., Northbrook, IL, USA. tomohiro.kusawake@astellas.com.
Donna KowalskiAstellas Pharma Global Development Inc., Northbrook, IL, USA.
Akitsugu TakadaAstellas Pharma Inc., Tokyo, Japan.
Kota KatoAstellas Pharma Inc., Tsukuba, Japan.
Masataka KatashimaAstellas Pharma Inc., Tokyo, Japan.
James J KeirnsAstellas Pharma Global Development Inc., Northbrook, IL, USA.
Michaelene LewandAstellas Pharma Global Development Inc., Northbrook, IL, USA.
Kenneth C LasseterClinical Pharmacology of Miami LLC, Miami, FL, USA.
Thomas C MarburyOrlando Clinical Research Center, Orlando, FL, USA.
Richard A PrestonDivision of Clinical Pharmacology, University of Miami, Miami, FL, USA.
Astellas Pharma (United States) · USAstellas Pharma (Japan) · JPClinical Pharmacology of Miami · USOrlando Clinical Research Center · USUniversity of Miami · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAmenamevir (ASP2151) is a nonnucleoside human herpesvirus helicase-primase inhibitor that was approved in Japan for the treatment of herpes zoster (shingles) in 2017. This article reports the results of two clinical trials that investigated the effects of renal and hepatic impairment on the pharmacokinetics of amenamevir.

methodsThese studies were phase 1, open-label, single-dose (oral 400 mg), parallel-group studies evaluating the pharmacokinetics, safety, and tolerability of amenamevir in healthy participants and participants with moderate hepatic impairment and mild, moderate, and severe renal impairment.

resultsIn the hepatic impairment study, the pharmacokinetic profile of amenamevir in participants with moderate hepatic impairment was generally similar to that of participants with normal hepatic function. In the renal impairment study, the area under the amenamevir concentration versus time curve from the time of dosing up to the time of the last sample with extrapolation to infinity of the terminal phase was increased by 78.1% in participants with severe renal impairment. There was a positive relationship between creatinine clearance and oral and renal clearance for amenamevir in the renal impairment study. In both studies, amenamevir was safe and well tolerated.

conclusionThe findings of the hepatic impairment study indicate that no dosing adjustment is required in patients with moderate hepatic impairment. In the renal impairment study, systemic amenamevir exposure was increased by renal impairment. However, it is unlikely that renal impairment will have a significant effect on the safety of amenamevir given that in previous pharmacokinetic and safety studies in healthy individuals amenamevir was safe and well tolerated after a single dose (5-2400 mg, fasted condition) and repeated doses for 7 days (300 or 600 mg, fed condition), and the amount of amenamevir exposure in the renal impairment study was covered by those studies. These findings suggest that amenamevir does not require dosage reduction in accordance with the creatinine clearance

fundingAstellas Pharma.

Indexed as

AdolescentAdultAgedAntiviral AgentsFemaleHerpes ZosterHumansJapanLiver DiseasesMaleMiddle AgedOxadiazolesRenal InsufficiencyYoung AdultAntiviral AgentsASP2151OxadiazolesAmenamevirHepatic impairmentHerpes zosterPharmacokineticsRenal impairmentSafety

Identifiers

PMID29134428
PMCPMC5709452
OpenAlexW2768106861

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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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.