Effects of ponesimod, a selective S1P1 receptor modulator, on the pharmacokinetics of a hormonal combination contraceptive

European Journal of Clinical Pharmacology

Volumn 70, Issue 3, 2014, Pages 287-293

  Reyes, Maribel ^a   Brossard, Patrick ^a   Chassard, Didier ^b   Hoch, Matthias ^a   Dingemanse, Jasper ^a  

^a ACTELION PHARMACEUTICALS LTD   (Switzerland)

^b Biotrial Paris   (France)

Author keywords

Ethinyl estradiol; Norethisterone; Oral contraceptive; Pharmacokinetics; Ponesimod; Sphingosine 1 phosphate receptor

Indexed keywords

ADULT; AREA UNDER CURVE; CONTRACEPTIVES, ORAL, COMBINED; CROSS-OVER STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG COMBINATIONS; DRUG INTERACTIONS; ETHINYL ESTRADIOL; FEMALE; HEART RATE; HUMANS; MIDDLE AGED; NORETHINDRONE; RECEPTORS, LYSOSPHINGOLIPID; THIAZOLES; TIME FACTORS;

EID: 84894452210     PISSN: 00316970     EISSN: 14321041     Source Type: Journal    
DOI: 10.1007/s00228-013-1625-2     Document Type: Article

References (31)

1. Bolli MH, Abele S, Binkert C, Bravo R, Buchmann S, Bur D, Gatfield J, Hess P, Kohl C, Mangold C, Mathys B, Menyhart K, Muller C, Nayler O, Scherz M, Schmidt G, Sippel V, Steiner B, Strasser D, Treiber A, Weller T (2010) 2-imino-thiazolidin-4-one derivatives as potent, orally active S1P1 receptor agonists. J Med Chem 53(10):4198-4211
2. Piali L, Froidevaux S, Hess P, Nayler O, Bolli MH, Schlosser E, Kohl C, Steiner B, Clozel M (2011) The selective sphingosine 1-phosphate receptor 1 agonist ponesimod protects against lymphocyte-mediated tissue inflammation. J Pharmacol Exp Ther 337(2):547-556
3. Brossard P, Derendorf H, Xu J, Maatouk H, Halabi A, Dingemanse J (2013) Pharmacokinetics and Pharmacodynamics of Ponesimod, a Selective S1P Receptor Modulator, in the First-in-Human Study. Br J Clin Pharmacol 76(6):888-896
4. Braley TJ, Segal BM (2013) B-Cell Targeting Agents in the Treatment of Multiple Sclerosis. Curr Treat Options Neurol. doi: 10.1007/s11940-013-0232-y
5. Cai Y, Fleming C, Yan J (2012) New insights of T cells in the pathogenesis of psoriasis. Cell Mol Immunol 9(4):302-309
6. Zaguia F, Saikali P, Ludwin S, Newcombe J, Beauseigle D, McCrea E, Duquette P, Prat A, Antel JP, Arbour N (2013) Cytotoxic NKG2C + CD4 T cells target oligodendrocytes in multiple sclerosis. J Immunol 190(6):2510-2518
7. Gambichler T, Zhang Y, Hoxtermann S, Kreuter A (2013) Natural killer cells and B lymphocytes in peripheral blood of patients with psoriasis. Br J Dermatol 168(4):894-896
8. Olsson T, Boster A, Fernández Ó, Freedman MS, Pozzilli C, Bach D, Berkani O, Mueller MS, Sidorenko T, Melanson M (2012) Efficacy and safety of ponesimod, an oral, selective sphingosine 1-phosphate receptor-1 modulator, in patients with relapsing-remitting multiple sclerosis: Results from a phase IIb, randomised, double-blind, placebo-controlled trial. Multiple Sclerosis Journal 18 (4 suppl) (49): 152
9. Freedman MS, Olsson T, Melanson M, Fernández Ó, Boster A, Bach D, Berkani O, Mueller MS, Sidorenko T, Pozzilli C (2012) Dose-dependent effect of ponesimod, an oral, selective sphingosine 1-phosphate receptor-1 modulator, on magnetic resonance imaging outcomes in patients with relapsing-remitting multiple sclerosis. Multiple Sclerosis Journal 18 (4 Suppl) (420): 923
10. Fernández Ó, Pozzilli C, Freedman MS, Olsson T, Melanson M, Bach D, Berkani O, Mueller MS, Sidorenko T, Boster A (2012) Pharmacodynamic effect, safety and tolerability of ponesimod, a selective sphingosine 1-phosphate receptor-1 modulator, in patients with relapsing-remitting multiple sclerosis. Multiple Sclerosis Journal 18 (4 Suppl):417
11. Chimenti S, Arenberger P, Karpati S, Vaclavkova A, Burcklen M, Stefani M, D'Ambrosio D (2013) A phase II study of ponesimod, an oral, selective sphingosine-1-phosphate receptor-1 modulator in chronic plaque psoriasis. 4th Congress of the Psoriasis Network, Paris, France
12. 1 receptor agonist: tolerability, safety, pharmacokinetics, and pharmacodynamics. Clin Pharmacol Ther 91:S93
13. Tseng A, Hills-Nieminen C (2013) Drug interactions between antiretrovirals and hormonal contraceptives. Expert Opin Drug Metab Toxicol 9(5):559-572
14. Barditch-Crovo P, Trapnell CB, Ette E, Zacur HA, Coresh J, Rocco LE, Hendrix CW, Flexner C (1999) The effects of rifampin and rifabutin on the pharmacokinetics and pharmacodynamics of a combination oral contraceptive. Clin Pharmacol Ther 65(4):428-438
15. Dutton C, Foldvary-Schaefer N (2008) Contraception in women with epilepsy: pharmacokinetic interactions, contraceptive options, and management. Int Rev Neurobiol 83:113-134
16. Hall SD, Wang Z, Huang SM, Hamman MA, Vasavada N, Adigun AQ, Hilligoss JK, Miller M, Gorski JC (2003) The interaction between St John's wort and an oral contraceptive. Clin Pharmacol Ther 74(6):525-535
17. Zhang H, Cui D, Wang B, Han YH, Balimane P, Yang Z, Sinz M, Rodrigues AD (2007) Pharmacokinetic drug interactions involving 17alpha-ethinylestradiol: a new look at an old drug. Clin Pharmacokinet 46(2):133-157
18. Miller MR, Crapo R, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J (2005) General considerations for lung function testing. Eur Respir J 26(1):153-161
19. Schwartz JB (1999) Oral contraceptive therapy in women: drug interactions and unwanted outcomes. J Gend Specif Med 2(6):26-29
20. LeBel M, Masson E, Guilbert E, Colborn D, Paquet F, Allard S, Vallee F, Narang PK (1998) Effects of rifabutin and rifampicin on the pharmacokinetics of ethinylestradiol and norethindrone. J Clin Pharmacol 38(11):1042-1050
21. WHO (2009) Department of Reproductive Health WHO. Medical eligibility criteria for contraceptive use. World Health Organization Fourth edition ed
22. Sekar VJ, Lefebvre E, Guzman SS, Felicione E, De Pauw M, Vangeneugden T, Hoetelmans RM (2008) Pharmacokinetic interaction between ethinyl estradiol, norethindrone and darunavir with low-dose ritonavir in healthy women. Antivir Ther 13(4):563-569
23. Wang B, Sanchez RI, Franklin RB, Evans DC, Huskey SE (2004) The involvement of CYP3A4 and CYP2C9 in the metabolism of 17 alpha-ethinylestradiol. Drug Metab Dispos 32(11):1209-1212
24. Hilbert J, Messig M, Kuye O, Friedman H (2001) Evaluation of interaction between fluconazole and an oral contraceptive in healthy women. Obstet Gynecol 98(2):218-223
25. Rosenfeld WE, Doose DR, Walker SA, Nayak RK (1997) Effect of topiramate on the pharmacokinetics of an oral contraceptive containing norethindrone and ethinyl estradiol in patients with epilepsy. Epilepsia 38(3):317-323
26. Sinofsky FE, Pasquale SA (1998) The effect of fluconazole on circulating ethinyl estradiol levels in women taking oral contraceptives. Am J Obstet Gynecol 178(2):300-304
27. Tsuchiya Y, Nakajima M, Yokoi T (2005) Cytochrome P450-mediated metabolism of estrogens and its regulation in human. Cancer Lett 227(2):115-124
28. Ouellet D, Hsu A, Qian J, Locke CS, Eason CJ, Cavanaugh JH, Leonard JM, Granneman GR (1998) Effect of ritonavir on the pharmacokinetics of ethinyl oestradiol in healthy female volunteers. Br J Clin Pharmacol 46(2):111-116
29. Back DJ, Orme ML (1990) Pharmacokinetic drug interactions with oral contraceptives. Clin Pharmacokinet 18(6):472-484
30. Rivera R, Yacobson I, Grimes D (1999) The mechanism of action of hormonal contraceptives and intrauterine contraceptive devices. Am J Obstet Gynecol 181(5 Pt 1):1263-1269
31. Lee R (2009) Drug interactions and hormonal contraception. Trend Urol Gyneacol Sex Health 14(3):23-26