A Clinical Trial to Evaluate the Effect of Nilotinib on the PK/PD of Meformin

Summary

The aim of the study is to evaluate the effect of nilotinib on the pharmacokinetics and pharmacodynamics of metformin in healthy male adults

Timeline

Start

2020-07-23

Primary completion

2020-09-07

Completion

2020-09-07

Publications

• Background Graham GG, Punt J, Arora M, Day RO, Doogue MP, Duong JK, Furlong TJ, Greenfield JR, Greenup LC, Kirkpatrick CM, Ray JE, Timmins P, Williams KM. Clinical pharmacokinetics of metformin. Clin Pharmacokinet. 2011 Feb;50(2):81-98. doi: 10.2165/11534750-000000000-00000.
• Background Chen EC, Liang X, Yee SW, Geier EG, Stocker SL, Chen L, Giacomini KM. Targeted disruption of organic cation transporter 3 attenuates the pharmacologic response to metformin. Mol Pharmacol. 2015 Jul;88(1):75-83. doi: 10.1124/mol.114.096776. Epub 2015 Apr 28.
• Background Kwon EY, Chung JY, Park HJ, Kim BM, Kim M, Choi JH. OCT3 promoter haplotype is associated with metformin pharmacokinetics in Koreans. Sci Rep. 2018 Nov 16;8(1):16965. doi: 10.1038/s41598-018-35322-6.
• Background Lapczuk-Romanska J, Busch D, Gieruszczak E, Drozdzik A, Piotrowska K, Kowalczyk R, Oswald S, Drozdzik M. Membrane Transporters in Human Parotid Gland-Targeted Proteomics Approach. Int J Mol Sci. 2019 Sep 28;20(19):4825. doi: 10.3390/ijms20194825.
• Background Lee N, Duan H, Hebert MF, Liang CJ, Rice KM, Wang J. Taste of a pill: organic cation transporter-3 (OCT3) mediates metformin accumulation and secretion in salivary glands. J Biol Chem. 2014 Sep 26;289(39):27055-27064. doi: 10.1074/jbc.M114.570564. Epub 2014 Aug 8.
• Background Minematsu T, Giacomini KM. Interactions of tyrosine kinase inhibitors with organic cation transporters and multidrug and toxic compound extrusion proteins. Mol Cancer Ther. 2011 Mar;10(3):531-9. doi: 10.1158/1535-7163.MCT-10-0731. Epub 2011 Jan 20.
• Background Rhee SJ, Choi Y, Lee S, Oh J, Kim SJ, Yoon SH, Cho JY, Yu KS. Pharmacokinetic and pharmacodynamic interactions between metformin and a novel dipeptidyl peptidase-4 inhibitor, evogliptin, in healthy subjects. Drug Des Devel Ther. 2016 Aug 10;10:2525-34. doi: 10.2147/DDDT.S110712. eCollection 2016.
• Background Jang K, Chung H, Yoon JS, Moon SJ, Yoon SH, Yu KS, Kim K, Chung JY. Pharmacokinetics, Safety, and Tolerability of Metformin in Healthy Elderly Subjects. J Clin Pharmacol. 2016 Sep;56(9):1104-10. doi: 10.1002/jcph.699. Epub 2016 Feb 22.
• Background Hwang CS, Kim JW, Al Sharhan SS, Kim JW, Cho HJ, Yoon JH, Kim CH. Development of a Gustatory Function Test for Clinical Application in Korean Subjects. Yonsei Med J. 2018 Mar;59(2):325-330. doi: 10.3349/ymj.2018.59.2.325.

Drugs

Indications

No indication recorded.