Pharmacokinetic assessment of a five-probe cocktail for CYPs 1A2, 2C9, 2C19, 2D6 and 3A

British Journal of Clinical Pharmacology

Volumn 68, Issue 6, 2009, Pages 928-935

  Turpault, Sandrine ^a   Brian, William ^a   Van Horn, Robert ^a   Santoni, Alix ^b   Poitiers, Franck ^b   Donazzolo, Yves ^c   Boulenc, Xavier ^b  

^a Global Metabolism and Pharmacokinetics   (United States)

^b SANOFI   (France)

^c Optimed   (France)

Author keywords

Cocktail; CYP; In vivo drug drug interaction

Indexed keywords

CAFFEINE; CYTOCHROME P450 1A2; CYTOCHROME P450 2C19; CYTOCHROME P450 2C9; CYTOCHROME P450 2D6; CYTOCHROME P450 3A; METOPROLOL; MIDAZOLAM; OMEPRAZOLE; PARAXANTHINE; WARFARIN;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CONTROLLED STUDY; DIZZINESS; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; FOOD DRUG INTERACTION; HEADACHE; HUMAN; HUMAN EXPERIMENT; LIQUID CHROMATOGRAPHY; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; PRIORITY JOURNAL; SINGLE DRUG DOSE; TANDEM MASS SPECTROMETRY;

ADMINISTRATION, ORAL; ADULT; ANTI-ANXIETY AGENTS; ANTI-ULCER AGENTS; ANTICOAGULANTS; AREA UNDER CURVE; CAFFEINE; CENTRAL NERVOUS SYSTEM STIMULANTS; CYTOCHROME P-450 CYP1A2; DRUG COMBINATIONS; DRUG INTERACTIONS; DRUG THERAPY, COMBINATION; HUMANS; MALE; METABOLIC CLEARANCE RATE; MIDAZOLAM; OMEPRAZOLE; WARFARIN; YOUNG ADULT;

EID: 70849124428     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2009.03548.x     Document Type: Article

References (17)

1. Chainuvati S, Nafziger AN, Leeder JS, Gaedigk A, Kearns GL, Sellers E, Zhang Y, Kashuba ADM, Rowland E, Bertino JS. Combined phenotypic assessment of CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP3A, NAT2 and XO with the Cooperstown 5+1 Cocktail. Clin Pharmacol Ther 2003 74 : 437 47.
2. Ryu JY, Song IS, Sunwoo YE, Shon JH, Liu KH, Cha IJ, Shin JG. Development of the 'Inje Cocktail' for high-throughput evaluation of five human cytochrome P450 isoforms in vivo. Clin Pharmacol Ther 2007 82 : 531 40.
3. Tomalik-Scharte D, Jetter A, Kinzig-Schippers M, Skott A, Sörgel F, Klaassen T, Kasel D, Harlfinger S, Doroshyenko O, Frank D, Kirchheiner J, Bräter M, Richter K, Gramatté T, Fuhr U. Effect of propiverine on cytochrome P450 enzymes: a cocktail interaction study in healthy volunteers. Drug Metab Dispos 2005 33 : 1859 66.
4. Schwagmeier R, Alincic S, Striebel HW. Midazolam pharmacokinetics following intravenous and buccal administration. Br J Clin Pharmacol 1998 46 : 203 6.
5. Zhou H, Tong Z, McLeod JF. 'Cocktail' approaches and strategies in drug development: valuable tool or flawed science? J Clin Pharmacol 2004 44 : 120 34.
6. Guengerich FP. Cytochromes P450, drugs, and diseases. Mol Interv 2003 3 : 194 204.
7. Yuen KH, Wong JW, Yap SP, Billa N. Estimated coefficient of variation values for sample size planning in bioequivalence studies. Int J Clin Pharmacol Ther 2001 39 : 37 40.
8. Efficacy working party: questions and answers on the use of Cocktail studies for investigating in vivo drug interaction potential. EMEA/CHMP/EWP/490784/2007.
9. Andersson T, Miners J-O, Tassaneeyakul W, Veronese ME, Meyer UA, Birkett DJ. Identification of human liver cytochrome P450 isoforms mediating omeprazole metabolism. Br J Clin Pharmacol 1993 36 : 521 30.
10. Andersson T, Bredberg E, Lagerstrom PO, Naesdal J, Wilson I. Lack of drug-drug interaction between three different non-steroidal anti-inflammatory drugs and omeprazole. Eur J Clin Pharmacol 1998 54 : 399 404.
11. Andersson T, Lundborg P, Regårdh CG. Lack of effect of omeprazole treatment on steady-state plasma levels of metoprolol. Eur J Clin Pharmacol 1991 40 : 61 5.
12. Andersson T, Bergstrand R, Cederberg C, Eriksson S, Lagerström PO, Skånberg I. Omeprazole treatment does not affect the metabolism of caffeine. Gastroenterology 1991 101 : 943 7.
13. Li G, Klotz U. Inhibitory effect of omeprazole on the metabolism of midazolam in vitro. Arzneimittelforschung 1990 40 : 1105 7.
14. McGourty JC, Silas JS, Lennard MS, Tucker GT, Woods HF. Metoprolol metabolism and debrisoquine oxidation polymorphism - population and family studies. Br J Clin Pharmacol 1985 20 : 555 66.
15. Schmider J, Brockmöller J, Arold G, Bauer S, Roots I. Simultaneous assessment of CYP3A4 and CYP1A2 activity in vivo with alprazolam and caffeine. Pharmacogenetics 1999 9 : 725 34.
16. Prueksaritanont T, Gorham LM, Ma B, Liu L, Yu X, Zhao JJ, Slaughter DE, Arison BH, Vyas KP. In vitro metabolism of simvastatin in humans [SBT] identification of metabolizing enzymes and effect of the drug on hepatic P450s. Drug Metab Dispos 1997 25 : 1191 9.
17. Streetman DS, Bleakley JF, Kim JS, Nafziger AN, Leeder JS, Gaedigk A, Gotschall R, Kearns GL, Bertino JS Jr. Combined phenotypic assessment of CYP1A2, CYP2C19, CYP2D6, CYP3A, N-acetyltransferase-2, and xanthine oxidase with the 'Cooperstown cocktail'. Clin Pharmacol Ther 2000 68 : 375 83.