The influence of hepatic impairment on the pharmacokinetics of paliperidone

International Journal of Clinical Pharmacology and Therapeutics

Volumn 47, Issue 10, 2009, Pages 606-616

  Boom, S ^a,d   Thyssen, A ^a   Crauwels, H ^a,e   Molz, K H ^b   Cleton, A ^a,d   Janssens, L ^a   Talluri, K ^c,f   Eerdekens, M ^a  

^a JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^b APEX GmbH   (Germany)

^c JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

^d Pharma Plus   (Netherlands)

^e Virco BVBA   (Belgium)

^f Compass Consulting International ^*  (United States)

Author keywords

Hepatic impairment; Paliperidone; Pharmacokinetics; Protein binding

Indexed keywords

ALBUMIN; PALIPERIDONE; PROLACTIN; 9 HYDROXY RISPERIDONE; 9-HYDROXY-RISPERIDONE; ISOXAZOLE DERIVATIVE; NEUROLEPTIC AGENT; PLASMA PROTEIN; PYRIMIDINE DERIVATIVE;

ADULT; AGED; ALBUMIN BLOOD LEVEL; AREA UNDER THE CURVE; ARTICLE; CLINICAL ARTICLE; CONTROLLED STUDY; DIZZINESS; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG PROTEIN BINDING; DRUG RELEASE; DRUG SAFETY; DRUG TOLERABILITY; ECG ABNORMALITY; FEMALE; HUMAN; HYPERPROLACTINEMIA; LIVER DISEASE; MALE; MAXIMUM PLASMA CONCENTRATION; PLASMA PROTEIN BINDING; PROLACTIN BLOOD LEVEL; SINGLE DRUG DOSE; CASE CONTROL STUDY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; METABOLISM; MIDDLE AGED; PATHOPHYSIOLOGY; PROTEIN BINDING;

ADULT; AGED; ANTIPSYCHOTIC AGENTS; BLOOD PROTEINS; CASE-CONTROL STUDIES; FEMALE; HUMANS; ISOXAZOLES; LIVER DISEASES; MALE; MIDDLE AGED; PROTEIN BINDING; PYRIMIDINES;

EID: 70350706273     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CPP47606     Document Type: Article

References (26)

1. Caccia S. New antipsychotic agents for schizophrenia: pharmacokinetics and metabolism update. Curr Opin Investig Drugs. 2002; 3: 1073-1080.
2. Cargiulo T. Understanding the health impact of alcohol dependence. Am J Health Syst Pharm. 2007; 64: 5-11.
3. Carney CP, Jones L, Woolson RF. Medical comorbidity in women and men with schizophrenia: a population-based controlled study. J Gen Intern Med. 2006; 21: 1133-1137.
4. Committe for Medicinal Products for Human Use. Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with impaired hepatic function. www.emea.europa.ey/pdfs/human/ewp/ 233902en.pdf. February 2005.
5. Davidson M, Emsley R, Kramer M, Ford L, Pan G, Lim P, Eerdekens M. Efficacy, safety and early response of paliperidone extended-release tablets (paliperidone ER): results of a 6-week, randomized, placebo-controlled study. Schizophr Res. 2007; 93: 117-130.
6. De Meulder M, Remmerie B, de Vries R, Sips L, Boom S, Hooijschuur E, van de Merbel N, Timmerman P. Validated LC-MS/MS method for the determination of risperidone and the enantiomers of 9-hydroxyrisperidone in human plasma and urine. J. Chrom. B. 2008; 870: 8-16.
7. Ereshefsky L. Pharmacokinetics and drug interactions: up date for new antipsychotics. J Clin Psychiatry. 1996; 57 (Suppl): 12-25.
8. FDA Guidance for Industry. Pharmacokinetics in patients with impaired hepatic function: study design, data analysis and impact on dosing and labeling. http://www.fda.giv/cber/gdlns/imphep.htm. May 2003.
9. Invega Prescribing Information. Janssen Pharmaceuticals, Titusville, NJ, USA. http://www.fda.giov/cder/foi/label/2006/ 021999lbl.pdf. Accessed January 2007.
10. Kane J, Canas F, Kramer M, Ford L, Gassmann-Mayer C, Lim P, Eerdekens M. Treatment of schizophrenia with paliperidone extended-release tablets: a 6-week placebo-controlled trial. Schizophr Res. 2007; 90: 147-161.
11. 2 receptor occupancy of clozapine, risperidone, and olanzapine in schizophrenia. Am J Psychiatry. 1999; 156: 286-293.
12. 2A receptor occupancy of paliperidone in healthy subjects: two open-label, single-dose studies. Clin Pharmacol Ther. 2006; 79: 74.
13. Kramer M, Simpson G, Maciulis V, Kushner S, Vijapurkar U, Lim P, Eerdekens M. Paliperidone extended-release tablets for prevention of symptom recurrence in patients with schizophrenia: a randomized, double-blind, placebo-controlled study. J Clin Psychopharmacol. 2007; 27: 6-14.
14. Lam YW, Banerji S, Hatfield C, Talbert RL. Principles of drug administration in renal insufficiency. Clin Pharmacokinet. 1997; 32: 30-57.
15. Lin JH, Lu AY. Role of pharmacokinetics and metabolism in drug discovery and development. Pharmacol Rev. 1997; 49: 403-449.
16. Mannens G, Huang ML, Meuldermans W, Hendrickx J, Woestenborghs R, Heykants J. Absorption, metabolism, and excretion of risperidone in humans. Drug Metab Dispos. 1993; 21: 1134-1141.
17. Mannens G, Meuldermans W, Snoeck E, Heykants J. Plasma protein binding of risperidone and its distribution in blood. Psychopharmacology (Berl). 1994; 114: 566-572.
18. Marder SR, Kramer M, Ford L, Eerdekens E, Lim P, Eerdekens M, Lowy A. Efficacy and safety of paliperidone extended-release tablets: results of a 6-week, randomized, placebo-controlled Study. Biol Psychiatry. 2007; 62: 1363-1370.
19. Megens AA, Awouters FHL. In vivo pharmacological profile of 9-hydroxyrisperidone the major metabolite of the novel antipsychotic risperidone. Drug Dev Res. 1994; 33: 399-412.
20. Rossenu S, Cleton A, Rusch S, Janssens L, Remmerie B, Warrington S, Eerdekens M, Boom S. Extended-release formulation of paliperidone shows dose-proportional pharmacokinetics. AAPS Journal. 2006a; 8 (Suppl): 3123.
21. Rossenu S, Crauwels H, Cleton A, Rusch S, Janssens L, Remmerie B, Mertens A, Eerdekens M, Boom S. Evaluation of the pharmacokinetics of several formulations of paliperidone. AAPS Journal. 2006b; 8 (Suppl): 1366.
22. Rossenu S, Vermeulen A, A C, Talluri K, Mertens A, L J, Youssef E, Boom S. A pharmacokinetic model to document the interconversion between the enantiomers of paliperidone. Presented at Society of Biological Psychiatry, Toronto, Canada, 18-20 May, 2006c.
23. Schotte A, Janssen PF, Gommeren W, Luyten WH, Van Gompel P, Lesage AS, De Loore K, Leysen JE. Risperidone compared with new and reference antipsychotic drugs: in vitro and in vivo receptor binding. Psychopharmacology (Berl). 1996; 124: 57-73.
24. Sokal J, Messias E, Dickerson FB, Kreyenbuhl J, Brown CH, Goldberg RW, Dixon LB. Comorbidity of medical illnesses among adults with serious mental illness who are receiving community psychiatric services. J Nerv Ment Dis. 2004; 192: 421-427.
25. Swartz MS, Wag ner HR, Swanson JW, Stroup TS, McEvoy JP, McGee M, Miller del D, Reimherr F, Khan A, Canive JM, Lieberman JA. Substance use and psychosocial functioning in schizophrenia among new enrollees in the NIMH CATIE study. Psychiatr Serv. 2006; 57: 1110-1116.
26. Vermeir M, Boom S, Naessen I, Talluri K, Eerdekens M. Absorption, metabolism and excretion of a single oral dose of 14C-paliperidone 1 mg in five healthy male subjects. Clin Pharmacol Ther. 2006; 79: 80.