Evidence map›Paper›PMID 39095578›Full record

ArticleDrugs in R&D2024

Pharmacokinetics, Tolerability, and Safety of Esmethadone in Subjects with Chronic Kidney Disease or Hepatic Impairment.

Nicola Ferri, Sara De Martin, James Stuart, Sergio Traversa, Andrea Mattarei, Stefano Comai, Franco Folli, Marco Pappagallo, Clotilde Guidetti, Charles E Inturrisi and 1 more

Abstract read
In one paragraph

Article in Drugs in R&D, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. 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

11 authors.

Nicola FerriDepartment of Medicine-DIMED, University of Padua, 35128, Padua, Italy. nicola.ferri@unipd.it.ORCID http://orcid.org/0000-0001-8898-7441
Sara De MartinDepartment of Pharmaceutical and Pharmacological Sciences, University of Padua, 35122, Padua, Italy.
James StuartRelmada Therapeutics, Coral Gables, FL, 33134, USA.
Sergio TraversaRelmada Therapeutics, Coral Gables, FL, 33134, USA.
Andrea MattareiDepartment of Pharmaceutical and Pharmacological Sciences, University of Padua, 35122, Padua, Italy.
Stefano ComaiDepartment of Pharmaceutical and Pharmacological Sciences, University of Padua, 35122, Padua, Italy.
Franco FolliDepartment of Health Sciences, University of Milan, 20122, Milan, Italy.
Marco PappagalloRelmada Therapeutics, Coral Gables, FL, 33134, USA.
Clotilde GuidettiChild and Adolescent Neuropsychiatry Unit, Department of Neuroscience, Bambino Pediatric Hospital, IRCCS, Rome, Italy.
Charles E InturrisiRelmada Therapeutics, Coral Gables, FL, 33134, USA.
Paolo L ManfrediRelmada Therapeutics, Coral Gables, FL, 33134, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesEsmethadone (dextromethadone; d-methadone; S-methadone (+)-methadone; REL-1017) is a low potency N-methyl-

methodsHere we studied the pharmacokinetics and safety of esmethadone after a single oral dose of 25 mg in subjects with different stages of kidney and liver impairment.

resultsIn subjects with a mild and moderate decrease in glomerular fraction rate (GFR), esmethadone C

conclusionMild and moderate hepatic impairment has a minimal to modest impact on exposure to total or unbound esmethadone and dose adjustments are not warranted in subjects with mild and moderate hepatic impairment. Administration of esmethadone was well tolerated in healthy adult subjects, in subjects with mild or moderate hepatic impairment, and in subjects with mild moderate or severe renal impairment, including patients with ESRF undergoing dialysis.

Indexed as

MethadoneRenal Insufficiency, ChronicAdministration, OralAdultAgedArea Under CurveFemaleGlomerular Filtration RateHumansLiver DiseasesMaleMiddle AgedYoung AdultMethadone

Identifiers

PMID39095578
PMCPMC11315824

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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.