Single-dose pharmacokinetic studies of abiraterone acetate in men with hepatic or renal impairment

Journal of Clinical Pharmacology

Volumn 54, Issue 7, 2014, Pages 732-741

  Marbury, Thomas ^a   Lawitz, Eric ^b   Stonerock, Robert ^a   Gonzalez, Martha ^c   Jiao, James ^c   Breeding, Jim ^c   Haqq, Christopher ^c   Verboven, Peter ^d   Stieltjes, Hans ^d   Yu, Margaret ^c   Molina, Arturo ^c   Acharya, Milin ^c   Chien, Caly ^c   Tran, Namphuong ^c  

^a ORLANDO CLINICAL RESEARCH CENTER   (United States)

^b UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

^c JANSSEN RESEARCH AND DEVELOPMENT   (United States)

^d JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

Author keywords

abiraterone acetate; hepatic impairment; pharmacokinetics; phase I; renal impairment

Indexed keywords

ABIRATERONE ACETATE; 17-(3-PYRIDYL)-5,16-ANDROSTADIEN-3BETA-ACETATE; ANDROSTANE DERIVATIVE; ANTINEOPLASTIC HORMONE AGONISTS AND ANTAGONISTS; CYTOCHROME P450 INHIBITOR; PRODRUG; STEROID 17ALPHA MONOOXYGENASE; SUSPENSION; TABLET;

ADULT; AGED; ARTICLE; BLOOD SAMPLING; CASTRATION RESISTANT PROSTATE CANCER; CLINICAL ARTICLE; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG PROTEIN BINDING; DRUG SAFETY; DRUG TOLERABILITY; END STAGE RENAL DISEASE; FLATULENCE; HUMAN; MALE; MILD HEPATIC IMPAIRMENT; MODERATE HEPATIC IMPAIRMENT; OPEN STUDY; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); RHINORRHEA; SEVERE HEPATIC IMPAIRMENT; SEVERE RENAL IMPAIRMENT; SINGLE DRUG DOSE; TABLET; TANDEM MASS SPECTROMETRY; ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY; VERY ELDERLY; ANTAGONISTS AND INHIBITORS; BLOOD; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; DRUG EFFECTS; HALF LIFE TIME; KIDNEY; KIDNEY FAILURE; KIDNEY FAILURE, CHRONIC; LIVER; LIVER FAILURE; METABOLISM; MIDDLE AGED; PATHOPHYSIOLOGY; PHASE 1 CLINICAL TRIAL; RENAL REPLACEMENT THERAPY; SEVERITY OF ILLNESS INDEX; SUSPENSION; URINARY EXCRETION;

ADULT; AGED; AGED, 80 AND OVER; ANDROSTADIENES; ANTINEOPLASTIC AGENTS, HORMONAL; CYTOCHROME P-450 ENZYME INHIBITORS; HALF-LIFE; HEPATIC INSUFFICIENCY; HUMANS; KIDNEY; KIDNEY FAILURE, CHRONIC; LIVER; MALE; MIDDLE AGED; PRODRUGS; RENAL DIALYSIS; RENAL ELIMINATION; RENAL INSUFFICIENCY; SEVERITY OF ILLNESS INDEX; STEROID 17-ALPHA-HYDROXYLASE; SUSPENSIONS; TABLETS;

EID: 84902011060     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1002/jcph.253     Document Type: Article

References (28)

1. Jarman M, Barrie SE, Llera JM., The 16,17-double bond is needed for irreversible inhibition of human cytochrome P45017alpha by abiraterone (17-(3-pyridyl) androsta-5,16-dien-3beta-ol) and related steroidal inhibitors. J Med Chem. 1998; 41 (27): 5375-5381. (Pubitemid 29031321)
2. Montgomery RB, Mostaghel EA, Vessella R, et al. Maintenance of intratumoral androgens in metastatic prostate cancer: a mechanism for castration-resistant tumor growth. Can Res. 2008; 68 (11): 4447-4454.
3. FDA approval for abiraterone acetate use with prednisone for metastatic castration-resistant prostate cancer before chemotherapy. Updated January 07, 2013 [cited June 10, 2013]; Available from: < http://www.cancer.gov/ cancertopics/druginfo/fda-abirateroneacetate >.
4. Danila DC, Morris MJ, de Bono JS, et al. Phase II multicenter study of abiraterone acetate plus prednisone therapy in patients with docetaxel-treated castration-resistant prostate cancer. J Clin Oncol. 2010; 28 (9): 1496-1501.
5. Ryan CJ, Smith MR, Fong L, et al. Phase I clinical trial of the CYP17 inhibitor abiraterone acetate demonstrating clinical activity in patients with castration-resistant prostate cancer who received prior ketoconazole therapy. J Clin Oncol. 2010; 28 (9): 1481-1488.
6. Attard G, Reid AH, Yap TA, et al. Phase I clinical trial of a selective inhibitor of CYP17, abiraterone acetate, confirms that castration-resistant prostate cancer commonly remains hormone driven. J Clin Oncol. 2008; 26 (28): 4563-4571.
7. Fizazi K, Scher HI, Molina A, et al. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomized, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2013; 13 (10): 983-992.
8. Ryan CJ, Smith MR, de Bono JS, et al. Abiraterone in metastatic prostate cancer without previous chemotherapy. New Eng J Med. 2013; 368 (2): 138-148.
9. ZYTIGA® prescribing information. December 2012 [cited June 06, 2013]; Available from: < http://www.zytiga.com/pdf/prescribing-information.pdf >.
10. Acharya M, Gonzalez M, Mannens M, et al. A phase-I, open-label, single-dose, mass balance study of 14C-labeled abiraterone acetate in healthy male subjects. Xenobiotica. 2012; 43 (4): 379-389.
11. Otterness DM, Wieben ED, Wood TC, et al. Human liver dehydroepiandrosterone sulfotransferase: molecular cloning and expression of cDNA. Mol Pharmacol. 1992; 41 (5): 865-872. (Pubitemid 23023329)
12. Hashimoto H, Toide K, Kitamura R, et al. Gene structure of CYP3A4, an adult-specific form of cytochrome P450 in human livers, and its transcriptional control. Eur J Biochem. 1993; 218 (2): 585-595. (Pubitemid 24003776)
13. Benet LZ, Hoener BA, Betty-Ann H., Changes in plasma protein binding have little clinical relevance. Clin Pharm Ther. 2002; 71 (3): 115-121. (Pubitemid 34271114)
14. Child CG, Turcotte JG., Surgery and portal hypertension. Major Probl Clin Surg. 1964; 1: 1-85.
15. Pugh RN, Murray-Lyon IM, Dawson JL, Pietroni MC, Williams R., Transection of the oesophagus for bleeding oesophageal varices. Br J Surg. 1973; 60: 646-649.
16. Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D., A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999 130: 461-470. (Pubitemid 29135798)
17. FDA.gov. Guidance for Industry. Pharmacokinetics in patients with impaired renal function-study design, data analysis, and impact on dosing and labeling. Revision 1. 2010 March 2010 [cited June 6, 2013]; Available from: < http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM204959.pdf >.
18. Guidance for Industry, Bioanalytical Method Validation, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, May 2001.
19. Shah VP, Midha KK, Findlay JW, et al. Bioanalytical method validation-a revisit with a decade of progress. Pharma Res. 2000; 17 (12): 1551-1557. (Pubitemid 32217566)
20. Viswanathan CT, Bansal S, Booth B, et al. Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. Pharma Res. 2007; 24 (10): 1962-1973. (Pubitemid 47389236)
21. Gibaldi M, Perrier D., Pharmacokinetics. 2nd ed. New York, NY: Marcel Dekker, Inc.; 1982.
22. National Institutes of Health, National Cancer Institute, Common Terminology Criteria for Adverse Events. Version 3.0. June 14, 2010 [cited June 2, 2013]; Available from: < http://ctep.cancer.gov/protocoldevelopment/ electronic-applications/docs/ctcaev3.pdf >.
23. FDA.gov. Guidance for Industry. Pharmacokinetics in patients with impaired hepatic function-study design, data analysis, and impact on dosing and labeling. May 2003 [cited June 7, 2013]; Available from: < http://www.fda.gov/OHRMS/DOCKETS/98fr/99D-5047-GDL00002.pdf >.
24. de Bono JS, Logothetis CJ, Molina A, et al. Abiraterone and increased survival in metastatic prostate cancer. N Eng J Med. 2011; 364 (21): 1995-2005.
25. Gong J, Gan J, Iyer RA., Identification of the oxidative and conjugative enzymes involved in the biotransformation of brivanib. Drug Metab Dispos. 2012; 40 (1): 219-226.
26. El-Khoueiry A, Posey JA, Ferrando JRC, et al. The effects of liver impairment on the pharmacokinetics of brivanib, a dual inhibitor of fibroblast growth factor receptor and vascular endothelial growth factor receptor tyrosine kinases. Cancer Chemother Pharmacol. 2013; 72 (1): 53-64.
27. Acharya M, Bernard A, Jiao J, et al. Bioequivalence of abiraterone acetate (AA) manufactured by either commercial or clinical trial process in healthy male subjects. Meeting abstract. In: The Annual Meeting of American Association of Pharmaceutical Scientists. Washington, DC, Oct 23-27, 2011: T3379.
28. Acharya M, Bernard A, Griffin T, et al. A phase 1 study to determine the effect of food on the pharmacokinetics of abiraterone acetate (AA) in healthy male subjects. Meeting abstract. In: The Annual Meeting of American Association of Pharmaceutical Scientists. Washington, DC, Oct 23-27, 2011.