Pharmacokinetic interaction study of ticagrelor and cyclosporine in healthy volunteers

Clinical Drug Investigation

Volumn 34, Issue 8, 2014, Pages 529-536

  Teng, Renli ^a   Kujacic, Mirjana ^b   Hsia, Judith ^a  

^a ASTRAZENECA   (United Kingdom)

^b ASTRAZENECA R AND D   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

ANTITHROMBOCYTIC AGENT; CYCLOSPORIN; CYCLOSPORIN A; DRUG METABOLITE; IMMUNOSUPPRESSIVE AGENT; TICAGRELOR; ADENOSINE; PURINERGIC P2Y RECEPTOR ANTAGONIST;

ACUTE CORONARY SYNDROME; AREA UNDER THE CURVE; ARTICLE; BLOOD LEVEL; BLOOD SAMPLING; COMORBIDITY; CROSSOVER PROCEDURE; DRUG BLOOD LEVEL; DRUG DISPOSITION; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; GRAFT REJECTION; HEADACHE; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; LIQUID CHROMATOGRAPHY; MALE; NAUSEA; NORMAL HUMAN; OPEN STUDY; PRIORITY JOURNAL; SINGLE DRUG DOSE; TANDEM MASS SPECTROMETRY; VIRUS INFECTION; VOMITING; ADULT; ANALOGS AND DERIVATIVES; CONTROLLED STUDY; DRUG INTERACTION; FOLLOW UP; PHYSIOLOGY; RANDOMIZED CONTROLLED TRIAL; YOUNG ADULT;

ADENOSINE; ADULT; CROSS-OVER STUDIES; CYCLOSPORINE; DRUG INTERACTIONS; FOLLOW-UP STUDIES; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MALE; PURINERGIC P2Y RECEPTOR ANTAGONISTS; YOUNG ADULT;

EID: 84904536113     PISSN: 11732563     EISSN: 11791918     Source Type: Journal    
DOI: 10.1007/s40261-014-0205-2     Document Type: Article

References (33)

1. Husted S. Evaluating the risk-benefit profile of the direct-acting P2Y(12) inhibitor ticagrelor in acute coronary syndromes. Postgrad Med. 2011;123(6):79-90.
2. Wallentin L, Becker RC, Budaj A, et al. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009;361(11):1045-57.
3. Butler K, Teng R. Pharmacokinetics, pharmacodynamics, safety and tolerability of multiple ascending doses of ticagrelor in healthy volunteers. Br J Clin Pharmacol. 2010;70(1):65-77.
4. Teng R, Butler K. Safety, tolerability, pharmacokinetics and pharmacodynamics of high single ascending doses of ticagrelor in healthy volunteers. Int J Clin Pharmacol Ther. 2013;51(10):795-806.
5. Teng R, Butler K. Pharmacokinetics, pharmacodynamics, tolerability and safety of single ascending doses of ticagrelor, a reversibly binding oral P2Y(12) receptor antagonist, in healthy subjects. Eur J Clin Pharmacol. 2010;66(5):487-96.
6. Teng R, Oliver S, Hayes M, et al. Absorption, distribution, metabolism, and excretion of ticagrelor in healthy subjects. Drug Metab Dispos. 2010;38(5):1514-21.
7. Teng R, Butler K. Comparison of the pharmacokinetics, pharmacodynamics and tolerability of single and multiple doses of ticagrelor in healthy Japanese and Caucasian volunteers. Int J Clin Pharmacol Ther. 2014 [Epub ahead of print].
8. Zhou D, Andersson TB, Grimm SW. In vitro evaluation of potential drug-drug interactions with ticagrelor: cytochrome P450 reaction phenotyping, inhibition, induction and differential kinetics. Drug Metab Dispos. 2011;39(4):703-10.
9. European Medicines Agency assessment report: ticagrelor (procedure no. EMEA/H/C/1241). http://www.ema.europa.eu/docs/en-GB/document-library/EPAR--- Public-assessment-report/human/001241/WC500100492.pdf. Accessed 10 April 2014.
10. Summary of product characteristics: Brilique. http://www.ema.europa.eu/ docs/en-GB/document-library/EPAR---Product-Information/human/001241/WC500100494. pdf. Accessed 10 April 2014.
11. Teng R, Butler K. The effect of ticagrelor on the metabolism of midazolam in healthy volunteers. Clin Ther. 2013;35(7):1025-37.
12. Teng R, Mitchell PD, Butler KA. Pharmacokinetic interaction studies of co-administration of ticagrelor and atorvastatin or simvastatin in healthy volunteers. Eur J Clin Pharmacol. 2013;69(9):477-87.
13. Teng R, Butler K. A pharmacokinetic interaction study of ticagrelor and digoxin in healthy volunteers. Eur J Clin Pharmacol. 2013;69(10):1801-8.
14. Colombo D, Ammirati E. Cyclosporine in transplantation - a history of converging timelines. J Biol Regul Homeost Agents. 2011;25(4):493-504.
15. Dehesa L, Abuchar A, Nuno-Gonazalez A, Vitiello M, Kerdel FA. The use of cyclosporine in dermatology. J Drugs Dermatol. 2012;11(8):979-87.
16. Gremese E, Ferraccioli GF. Benefit/risk of cyclosporine in rheumatoid arthritis. Clin Exp Rheumatol. 2004;22(5 Suppl 35):S101-7. (Pubitemid 39328361)
17. Kusuhara H, Sugiyama Y. Drug-drug interactions involving the membrane transport process. In: Rodrigues AD, editor. Drug-drug interactions. New York: Marcel Dekker; 2001. p. 123-88.
18. Krishna R, Bergman A, Larson P, et al. Effect of a single cyclosporine dose on the single-dose pharmacokinetics of sitagliptin (MK-0431), a dipeptidyl peptidase-4 inhibitor, in healthy male subjects. J Clin Pharmacol. 2007;47(2):165-74. (Pubitemid 46146482)
19. Kumar A, Cannon CP. Acute coronary syndromes: diagnosis and management. Mayo Clin Proc. 2009;84(10):917-38.
20. Taneva E, Bogdanova V, Shtereva N. Acute coronary syndrome, comorbidity, and mortality in geriatric patients. Ann N Y Acad Sci. 2004;1019:106-10. (Pubitemid 38951292)
21. Kasiske BL, Maclean JR, Snyder JJ. Acute myocardial infarction and kidney transplantation. J Am Soc Nephrol. 2006;17(3):900-7.
22. Boehncke WH, Boehncke S. Cardiovascular mortality in psoriasis and psoriatic arthritis: epidemiology, pathomechanisms, therapeutic implications, and perspectives. Curr Rheumatol Rep. 2012;14(4):343-8.
23. Charles-Schoeman C. Cardiovascular disease and rheumatoid arthritis: an update. Curr Rheumatol Rep. 2012;14(5):455-62.
24. Xu T, Zhang YH. Association of psoriasis with stroke and myocardial infarction: meta-analysis of cohort studies. Br J Dermatol. 2012;167(6):1345-50.
25. Sakuma T, Kawasaki Y, Jarukamjorn K, Nemoto N. Sex differences of drug-metabolizing enzyme: female predominant expression of human and mouse cytochrome P450 3A isoforms. J Health Sci. 2009;55(3):325-37.
26. Sillén H, Cook M, Davis P. Determination of ticagrelor and two metabolites in plasma samples by liquid chromatography and mass spectrometry. J Chromatogr B. 2010;878(25):2299-306.
27. Teng R, Butler K. Effect of the CYP3A inhibitors, diltiazem and ketoconazole, on ticagrelor pharmacokinetics in healthy volunteers. J Drug Assess. 2013;2:30-9.
28. von Richter O, Burk O, Fromm MF, Thon KP, Eichelbaum M, Kivisto KT. Cytochrome P450 3A4 and P-glycoprotein expression in human small intestinal enterocytes and hepatocytes: a comparative analysis in paired tissue specimens. Clin Pharmacol Ther. 2004;75(3):172-83. (Pubitemid 38314866)
29. Glaeser H. Importance of P-glycoprotein for drug-drug interactions. Handb Exp Pharmacol. 2011;201:285-97.
30. FDA. Guidance for industry. Drug interaction studies - study design, data analysis, implications for dosing, and labelling recommendations. Draft guidance. Food and Drug Administration, February 2012. http://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm292362.pdf. Accessed 06 Feb 2014.
31. Elsby R, Hilgendorf C, Fenner K. Understanding the critical disposition pathway of statins to assess drug-drug interaction risk during drug development: it's just about OATP1B1. Clin Pharmacol Ther. 2012;95(5):584-98.
32. Husted S, Emanuelsson H, Heptinstall S, et al. Pharmacodynamics, pharmacokinetics, and safety of the oral reversible P2Y12 antagonist AZD6140 with aspirin in patients with atherosclerosis: a double-blind comparison to clopidogrel with aspirin. Eur Heart J. 2006;27(9):1038-47.
33. Storey RF, Husted S, Harrington RA, et al. Inhibition of platelet aggregation by AZD6140, a reversible oral P2Y12 receptor antagonist, compared with clopidogrel in patients with acute coronary syndromes. J Am Coll Cardiol. 2007;50(19):1852-6. (Pubitemid 350017792)