Investigation of sarizotan's impact on the pharmacokinetics of probe drugs for major cytochrome P450 isoenzymes: A combined cocktail trial

European Journal of Clinical Pharmacology

Volumn 62, Issue 4, 2006, Pages 277-284

  Krösser, Sonja ^a   Neugebauer, Roland ^a   Dolgos, Hugues ^a   Fluck, Markus ^a   Rost, Karl Ludwig ^b   Kovar, Andreas ^a  

^a MERCK KGAA   (Germany)

^b PAREXEL INTERNATIONAL   (United States)

Author keywords

Cytochrome P450; Drug cocktail; Drug drug interactions; Sarizotan

Indexed keywords

ALPHA HYDROXYMETOPROLOL; CAFFEINE; CYTOCHROME P450; DICLOFENAC; MEPHENYTOIN; METOPROLOL; MIDAZOLAM; PARAXANTHINE; PLACEBO; SARIZOTAN;

ADULT; ARTICLE; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; HUMAN; MALE; METABOLIC RATE; NORMAL HUMAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; STEADY STATE; UNSPECIFIED SIDE EFFECT; URINALYSIS; URINARY EXCRETION;

ADOLESCENT; ADULT; ANTIPARKINSON AGENTS; ARYL HYDROCARBON HYDROXYLASES; CROSS-OVER STUDIES; CYTOCHROME P-450 CYP1A2; CYTOCHROME P-450 CYP2D6; CYTOCHROME P-450 ENZYME SYSTEM; DOUBLE-BLIND METHOD; DRUG INTERACTIONS; HUMANS; ISOENZYMES; MALE; MIXED FUNCTION OXYGENASES; MOLECULAR PROBES; ORGANIC CHEMICALS; PHARMACOKINETICS;

EID: 33645686908     PISSN: 00316970     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00228-006-0101-7     Document Type: Article

References (28)

1. Backman JT, Aranko K, Himberg JJ, and Olkkola KT (1994) A pharmacokinetic interaction between roxithromycin and midazolam. Eur J Clin Pharmacol 46:551-555
2. Bertilsson Leif, Dahl Marja-Liisa, Dalén Per, Al-Shurbaji Ayman (2002) Molecular genetics of CYP2D6: clinical relevance with focus on psychotropic drugs. Br J Clin Pharmacol 53:111-122
3. 1A agonist improves motor complications in rodent and primate Parkinsonian models. Neurology 57:1829-1934
4. Bjornsson TD, Callaghan JT, Einolf HJ, Fischer V, Gan L, Grimm S, Kao J, King P, Miwa G, Ni L, Kumar G, McLeod J, Obach SR, Roberts S, Roe A, Shah A, Snikeris F, Sullivan JT, Tweedie D, Vega JM, Walsh J, Wrighton A (2003) The conduct of in vitro and in vivo drug drug interaction studies: A PhRMA perspective. J Clin Pharmacol 43:443-469
5. Bruce MA, Hall SD, Haehner-Daniels BD, Gorski JC (2001) In vivo effect of clarithromycin on multiple cytochrome P450s. Drug Metab Dispos 29:1023-1028
6. Ceravolo R, Nuti A, Piccinni A, Dell'Agnello G, Bellini G, Gambaccini G, Dell'Osso L, Murri L, Bonuccelli U (2000) Paroxetine in Parkinson's disease: effects on motor and depressive symptoms. Neurology 55:1216-1218
7. EUFEPS Conference report (2001) Optimising drug development: strategies to assess drug metabolism/transporters interaction potential - towards a consensus. Eur J Pharm Sci 13:417-428
8. Frye F, Matzke GR, Adenoyin A (1997) Validation of the five-drug "Pittsburgh cocktail" approach for assessment of selective regulation of drug-metabolizing enzymes. Clin Pharmacol Ther 62:365-376
9. Hewitt NJ, Bühring KU, Dasenbrock J, Haunschild J, Ladstetter B, Utesch D (2001) Studies comparing in vivo: in vitro metabolism of three pharmaceutical compounds in rat, dog, monkey, and human using cryopreserved hepatocytes, microsomes, and collagen gel immobilized hepatocyte cultures. Drug Metab Disp 29:1042-1050
10. Hoefer C, Galleman D, Fluck F, Buhring KU, Ladestter B, Dolgos H. An in vitro assessment of sarizotan inhibitory and induction potential towards major hepatic cytochromes P450, in preparation
11. Kay OM, Gallemann D, Fluck F, Buhring KU, Ladestter B, Dolgos H. An in vitro assessment of sarizotan inhibitory and induction potential towards major hepatic cytochromes P450, in preparation
12. Kirchheiner J, Meineke I, Müller G, Roots I, Brockmöller J (2002) Contributions of CYP2D6, CYP 2C9 and CYP2C19 to the biotransformation of E-and Z doxepine in healthy volunteers. Pharmacogenetics 12:571-579
13. Leucuta A, Vlase L, Farcau D, Nanulescu M (2004) No effect of short term ranitidine intake on diclofenac pharmacokinetics. Rom J Gastroenterol 13:306-308
14. Nelson MV, Berchou RC, Kareti D, LeWitt PA (1990) Pharmacokinetic evaluation of erythromycin and caffeine administered with bromocriptine. Clin Pharmacol Ther 47:694-697
15. Olanow CW, Damier P, Goetz CG, Mueller T, Nutt J, Rascol O, Serbanescu A, Deckers F, Russ H (2004) Multicenter, openlable, trial of Sarizotan in Parkinson Disease patients with levodopa-induced dyskinesia (the SPLENDID Study) Clin Neuropharmacol 27:58-62
16. Olanow CW, Watts RL, Koller WC (2001) An algorithm (decision tree) for management of Parkinson's disease. Treatment guidelines. Neurology 56 (S5):1-88
17. Palmer JL, Scott RJ, Gibson A, Dickins M, Pleasance S (2001) An interaction between the cytochrome P450 probe substrates chlorzoxazone (CYP2E1) and midazolam (CYP3A4). Br J Clin Pharmacol 52:555-561
18. Regardh CG, Landahl S, Larsson M, Lundborg P, Stehen B, Hoffmann KJ, Langerström PO (1983) Pharmacokinetics of metoprolol and its metabolite α-hydroxymetoprolol in health, non-smoking, elderly individuals. Eur J Clin Pharmacol 24:221-226
19. Richard IH (2000) Depression in Parkinson's disease. Curr Treat Op Neurol 2:263-274
20. Scott RJ, Palmer J, Lewis IAS, Pleasance S (1999) Determination of a "GW cocktail" of cytochrome P450 probe substrates and their metabolites in plasma and urine using automated solid phase extraction and fast gradient liquid chromatography tandem mass spectrometry. Rapid Commun Mass Spectrom 13:2305-2319
21. Suchowersky O (2002) Parkinson's disease: medical treatment of moderate to advanced disease. Curr Neurol Neurosci Rep 2:310-316
22. Sugiyama Y, Kato Y, Ito K (2002) Quantitative prediction: metabolism, Transport in the liver. In Li A, Sugiyama Y (Eds) Preclinical and clinical evaluation of drug - drug interactions, I S E Press, 108-115
23. Tamminga WJ, Wemer J, Oosterhuis B, Brakenhoff JP, Gerrits MG, de Zeeuw RA, de Leij LF, Jonkman JH (2001) An optimized methodology for combined phenotyping and genotyping on CYP2D6 and CYP2C19. Eur J Clin Pharmacol 57:143-146
24. The European Agency for the Evaluation of Medicinal Products, Committee for proprietary medicinal products (1997) Not for Guidance on the investigation of drug interactions (CPMP/EWP/560/95)
25. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER)(1998) Guidance for Industry: In vivo Drug metabolism/Drug Interaction Studies - Study Design, Data Analysis, and Recommendations for Dosing and Labeling
26. Wrighton SA, Schuetz EG, Thummel KE, Shen DD, Korzenka KR, Watkins PB (2000) The human CYP3A subfamily practical considerations. Drug Metab Rev 32:339-361
27. Zhou H, Tong Z, Mc Leod J (2004) "Cocktail " Approaches and Strategies in Drug Development: Valuable tool or flawed science? J Clin Pharmacol 44:120-134
28. Zhu B, Ou-Yang DS, Chen XP, Huang SL, Tan ZR, He N, Zhou HH (2001) Assessment of cytochrome P450 activity by a five-drug cocktail approach. Clin Pharmacol Ther 70:455-461, DOI:10.1067/mcp.2001.119813