Pharmacokinetics and pharmacodynamics of cinacalcet in hepatic impairment: Phase I, open-label, parallel-group, single-dose, single-centre study

Clinical Drug Investigation

Volumn 28, Issue 10, 2008, Pages 635-643

  Padhi, Desmond ^a   Harris, Robert Z ^a   Salfi, Margaret ^a   Noveck, Robert J ^b   Sullivan, John T ^a  

^a AMGEN INC   (United States)

^b MDS Inc   (Canada)

Author keywords

Cinacalcet, pharmacodynamics; Cinacalcet, pharmacokinetics; Dialysis; Kidney disorders; Liver dysfunction

Indexed keywords

CALCIUM; CALCIUM ION; CINACALCET; PARATHYROID HORMONE; PHOSPHORUS;

AGED; AREA UNDER THE CURVE; ARTICLE; CALCIUM BLOOD LEVEL; CLINICAL ARTICLE; CLINICAL TRIAL; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG HALF LIFE; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HEADACHE; HUMAN; LIQUID CHROMATOGRAPHY; LIVER DYSFUNCTION; LIVER FUNCTION; MALE; MASS SPECTROMETRY; MAXIMUM PLASMA CONCENTRATION; MYALGIA; NAUSEA; OPEN STUDY; OUTCOME ASSESSMENT; PARALLEL DESIGN; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL; PHOSPHATE BLOOD LEVEL; PRIORITY JOURNAL; PROTEIN BINDING; SINGLE DRUG DOSE; UPPER RESPIRATORY TRACT INFECTION;

ADMINISTRATION, ORAL; AGED; AREA UNDER CURVE; CALCIUM; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; FEMALE; HALF-LIFE; HEADACHE; HUMANS; IMMUNOASSAY; LIVER; LIVER DISEASES; MALE; MASS SPECTROMETRY; METABOLIC CLEARANCE RATE; MIDDLE AGED; NAPHTHALENES; NAUSEA;

EID: 51649084760     PISSN: 11732563     EISSN: None     Source Type: Journal    
DOI: 10.2165/00044011-200828100-00004     Document Type: Article

References (17)

1. Slatopolsky E, Brown A, Dusso A. Pathogenesis of secondary hyperparathyroidism. Kidney Int 1999 Dec; 73 Suppl.: S14-9
2. Block GA, Klassen PS, Lazarus JM, et al. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol 2004 Aug; 15 (8): 2208-18
3. Young EW, Akiba T, Albert JM, et al. Magnitude and impact of abnormal mineral metabolism in hemodialysis patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis 2004 Nov; 44 (5 Suppl. 3): 34-8
4. Brown EM, Gamba G, Riccardi D, et al. Cloning and characterization of an extracellular Ca(2+)-sensing receptor from bovine parathyroid. Nature 1993 Dec 9; 366 (6455): 575-80
5. Nemeth EF, Heaton WH, Miller M, et al. Pharmacodynamics of the type II calcimimetic compound cinacalcet HCl. J Pharmacol Exp Ther 2004 Feb; 308 (2): 627-35
6. Block GA, Martin KJ, de Francisco AL, et al. Cinacalcet for secondary hyperparathyroidism in patients receiving hemodialysis. N Engl J Med 2004 Apr 8; 350 (15): 1516-25
7. Lindberg JS, Culleton B, Wong G, et al. Cinacalcet HCl, an oral calcimimetic agent for the treatment of secondary hyperparathyroidism in hemodialysis and peritoneal dialysis: a randomized, double-blind, multicenter study. J Am Soc Nephrol 2005 Mar; 16 (3): 800-7
8. Padhi D, Harris RZ, Salfi M, et al. No effect of renal function or dialysis on pharmacokinetics of cinacalcet (Sensipar/Mimpara). Clin Pharmacokinet 2005; 44 (5): 509-16
9. Data on file. Amgen, Inc., Thousand Oaks, CA, USA
10. Amgen Inc. Sensipar® (cinacalcet HCl) prescribing information, 2004 [online]. Available from URL: http://www.sensipar.com/prescribingInfo.jsp [Accessed 2006 Jan 11]
11. Kumar GN, Sproul C, Poppe L, et al. Metabolism and disposition of calcimimetic agent cinacalcet HCl in humans and animal models. Drug Metab Dispos 2004 Dec; 32 (12): 1491-500
12. Forns X, Fernandez-Llama P, Costa J, et al. Hepatitis G virus infection in a haemodialysis unit: prevalence and clinical implications. Nephrol Dial Transplant 1997 May; 12 (5): 956-60
13. Finelli L, Miller JT, Tokars JI, et al. National surveillance of dialysis-associated diseases in the United States, 2002. Semin Dial 2005 Jan-Feb; 18 (1): 52-61
14. Pugh RN, Murray-Lyon IM, Dawson JL, et al. Transection of the oesophagus for bleeding oesophageal varices. Br J Surg 1973 Aug; 60 (8): 646-9
15. Wood AJ, Kornhauser DM, Wilkinson GR, et al. The influence of cirrhosis on steady-state blood concentrations of unbound propranolol after oral administration. Clin Pharmacokinet 1978 Nov-Dec; 3 (6): 478-87
16. Harris RZ, Padhi D, Marbury TC, et al. Pharmacokinetics, pharmacodynamics, and safety of cinacalcet hydrochloride in hemodialysis patients at doses up to 200mg once daily. Am J Kidney Dis 2004 Dec; 44 (6): 1070-6
17. National Kidney Foundation. K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Am J Kidney Dis 2003 Oct; 42 (4 Suppl. 3): S1-201