Pharmacokinetics of Imeglimin in Caucasian and Japanese Healthy Subjects.
Journal
Clinical drug investigation
ISSN: 1179-1918
Titre abrégé: Clin Drug Investig
Pays: New Zealand
ID NLM: 9504817
Informations de publication
Date de publication:
Sep 2022
Sep 2022
Historique:
accepted:
03
07
2022
pubmed:
23
7
2022
medline:
2
9
2022
entrez:
22
7
2022
Statut:
ppublish
Résumé
Imeglimin is a first-in-class novel oral antidiabetic marketed in Japan as TWYMEEG To assess the pharmacokinetic and safety profile of imeglimin in Caucasian and Japanese healthy individuals. Two randomized placebo-controlled phase 1 clinical studies were conducted in Caucasian subjects after single (250-8000 mg) and multiple (250-2000 mg twice daily) ascending doses and in Japanese subjects after single (500-6000 mg) and multiple (500-2000 mg twice daily) ascending doses. Imeglimin plasma and urine concentrations were measured. All imeglimin doses achieved maximal concentration between 1 and 3.5 h in Caucasians, and 1.5 and 3 h in Japanese subjects. The elimination half-lives (t Imeglimin was safe and well tolerated in these two phases 1 studies, with pharmacokinetics comparable between the two populations. EudraCT 2005-001946-18 and 2014-004679-21.
Sections du résumé
BACKGROUND
BACKGROUND
Imeglimin is a first-in-class novel oral antidiabetic marketed in Japan as TWYMEEG
OBJECTIVE
OBJECTIVE
To assess the pharmacokinetic and safety profile of imeglimin in Caucasian and Japanese healthy individuals.
METHODS
METHODS
Two randomized placebo-controlled phase 1 clinical studies were conducted in Caucasian subjects after single (250-8000 mg) and multiple (250-2000 mg twice daily) ascending doses and in Japanese subjects after single (500-6000 mg) and multiple (500-2000 mg twice daily) ascending doses. Imeglimin plasma and urine concentrations were measured.
RESULTS
RESULTS
All imeglimin doses achieved maximal concentration between 1 and 3.5 h in Caucasians, and 1.5 and 3 h in Japanese subjects. The elimination half-lives (t
CONCLUSION
CONCLUSIONS
Imeglimin was safe and well tolerated in these two phases 1 studies, with pharmacokinetics comparable between the two populations.
CLINICAL TRIAL REGISTRATIONS
BACKGROUND
EudraCT 2005-001946-18 and 2014-004679-21.
Identifiants
pubmed: 35867199
doi: 10.1007/s40261-022-01181-3
pii: 10.1007/s40261-022-01181-3
pmc: PMC9427879
doi:
Substances chimiques
Triazines
0
imeglimin
UU226QGU97
Types de publication
Clinical Trial, Phase I
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
721-732Informations de copyright
© 2022. The Author(s).
Références
Am J Clin Nutr. 2005 Mar;81(3):555-63
pubmed: 15755822
Diabetes Care. 2014 Jul;37(7):1924-30
pubmed: 24722500
J Diabetes Investig. 2022 Jan;13(1):34-41
pubmed: 34523242
Am J Epidemiol. 2004 Jun 15;159(12):1150-9
pubmed: 15191932
Clin Pharmacokinet. 2020 Oct;59(10):1261-1271
pubmed: 32270440
Cell Death Discov. 2016 Jan 18;2:15072
pubmed: 27551496
Diabetes Obes Metab. 2014 Oct;16(10):900-9
pubmed: 24655583
Drug Metab Dispos. 2020 Dec;48(12):1330-1346
pubmed: 33020063
Am J Kidney Dis. 2009 Jun;53(6):982-92
pubmed: 19339088
Clin Transl Sci. 2022 Apr;15(4):1014-1026
pubmed: 34962074
Diabetes. 2015 Jun;64(6):2254-64
pubmed: 25552598
Endocrinol Diabetes Metab. 2020 Nov 07;4(2):e00193
pubmed: 33855202
Diabetologia. 2013 Apr;56(4):696-708
pubmed: 23344728
Endocrinol Diabetes Metab. 2021 Feb 23;4(2):e00211
pubmed: 33855213
Diabetes Obes Metab. 2021 Mar;23(3):664-673
pubmed: 33269554
Eur J Drug Metab Pharmacokinet. 2020 Dec;45(6):725-733
pubmed: 32860624
Methods Mol Biol. 2012;929:377-89
pubmed: 23007438
Drugs R D. 2015 Sep;15(3):227-32
pubmed: 26254210
Diabetes Obes Metab. 2012 Sep;14(9):852-8
pubmed: 22519919
Diabetes Obes Metab. 2021 Mar;23(3):800-810
pubmed: 33275318
Diabetes Obes Metab. 2015 Jun;17(6):541-545
pubmed: 25694060
PLoS One. 2021 Feb 19;16(2):e0241651
pubmed: 33606677
Diabetes Care. 2013 Mar;36(3):565-8
pubmed: 23160726
Diabetes Obes Metab. 2022 Apr;24(4):609-619
pubmed: 34866306
Diabetes Obes Metab. 2022 May;24(5):838-848
pubmed: 34984815
Diabetes Care. 2021 Apr;44(4):952-959
pubmed: 33574125