Pharmacokinetics of Imeglimin in Subjects with Moderate Hepatic Impairment.
Journal
Clinical pharmacokinetics
ISSN: 1179-1926
Titre abrégé: Clin Pharmacokinet
Pays: Switzerland
ID NLM: 7606849
Informations de publication
Date de publication:
04 2021
04 2021
Historique:
accepted:
04
10
2020
pubmed:
11
11
2020
medline:
16
10
2021
entrez:
10
11
2020
Statut:
ppublish
Résumé
Imeglimin is a novel oral antidiabetic drug used to treat type 2 diabetes, targeting the mitochondrial bioenergetics. Imeglimin is mainly excreted unchanged by the kidneys and is a substrate of organic cation transporters, which are expressed in the kidney and the liver. The aim of this study was to assess the effect of hepatic impairment on the pharmacokinetics of imeglimin. An open-label, single-dose, parallel-group study was carried out in seven subjects with normal hepatic function and seven subjects with moderate hepatic impairment who received a single dose of imeglimin 1000 mg. Blood and urine samples were collected up to 48 h after imeglimin administration. Pharmacokinetics were determined using non-compartmental methods. Imeglimin maximum observed plasma concentration (C Imeglimin was safe and well tolerated in all subjects. EudraCT 2018-001950-83.
Sections du résumé
BACKGROUND
Imeglimin is a novel oral antidiabetic drug used to treat type 2 diabetes, targeting the mitochondrial bioenergetics. Imeglimin is mainly excreted unchanged by the kidneys and is a substrate of organic cation transporters, which are expressed in the kidney and the liver.
OBJECTIVE
The aim of this study was to assess the effect of hepatic impairment on the pharmacokinetics of imeglimin.
METHODS
An open-label, single-dose, parallel-group study was carried out in seven subjects with normal hepatic function and seven subjects with moderate hepatic impairment who received a single dose of imeglimin 1000 mg. Blood and urine samples were collected up to 48 h after imeglimin administration. Pharmacokinetics were determined using non-compartmental methods.
RESULTS
Imeglimin maximum observed plasma concentration (C
CONCLUSIONS
Imeglimin was safe and well tolerated in all subjects.
CLINICAL TRIAL REGISTRATION
EudraCT 2018-001950-83.
Identifiants
pubmed: 33169345
doi: 10.1007/s40262-020-00948-1
pii: 10.1007/s40262-020-00948-1
doi:
Substances chimiques
Triazines
0
imeglimin
UU226QGU97
Banques de données
EudraCT
['2018-001950-83']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
485-490Références
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