Pharmacokinetic and pharmacodynamic modeling of a copper-selective chelator (TETA) in healthy adults

Journal of Clinical Pharmacology

Volumn 49, Issue 8, 2009, Pages 916-928

  Cho, Hea Young ^a   Blum, Robert A ^b   Sunderland, Tracey ^c   Cooper, Garth J S ^d   Jusko, William J ^a  

^a UNIVERSITY AT BUFFALO   (United States)

^b Buffalo Clinical Research Center   (United States)

^c UNIVERSITY OF AUCKLAND   (New Zealand)

^d UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

Copper; Human subjects; Pharmacodynamics; Pharmacokinetics; Triethylenetetramine

Indexed keywords

GC 811007; PLACEBO; TRIENTINE; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG ABSORPTION; DRUG CLEARANCE; DRUG DOSE ESCALATION; DRUG ELIMINATION; DRUG EXCRETION; DRUG TOLERABILITY; FEMALE; HEADACHE; HUMAN; MALE; NAUSEA; NORMAL HUMAN; PATIENT ASSESSMENT; PHASE 1 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; STOMACH DISCOMFORT; UPPER ABDOMINAL PAIN; ZINC URINE LEVEL;

ADOLESCENT; ADULT; CHELATING AGENTS; COPPER; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; GLOMERULAR FILTRATION RATE; HUMANS; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; NONLINEAR DYNAMICS; PROSPECTIVE STUDIES; SEX FACTORS; TRIETHYLENETETRAMINE; YOUNG ADULT;

EID: 70349266839     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270009337939     Document Type: Article

References (15)

1. Protocol GC007-6: A Dose Ranging Study of the Safety, Pharmacokinetics and Pharmacodynamics of GC811007 Administration in Healthy Adult Volunteers. Auckland, New Zealand: Protemix Corporation Ltd ; 2004.
2. Cooper GJ, Chan YK, Dissanayake AM, et al. Demonstration of a hyperglycemia driven pathogenic abnormality of copper homeostasis in diabetes and its reversibility by selective chelation. Diabetes. 2005 ; 54: 1468-1476.
3. Cooper GJ, Phillips AR, Choong SY, et al. Regeneration of the heart in diabetes by selective copper chelation. Diabetes. 2004 ; 53: 2501-2508.
4. Struthers AD, Morris AD Screening for and treating left-ventricular abnormalities in diabetes mellitus: a new way of reducing cardiac deaths. Lancet. 2002 ; 359: 1430-1432.
5. Gong D., Lu J., Chen X., et al. A copper (II)-selective chelator ameliorates diabetes-evoked renal fibrosis and albuminuria, and suppresses pathogenic TGF-β activation in the kidneys of rats used as a model of diabetes. Diabetologia. 2008 ; 51: 1741-1751.
6. Kodama H., Murata Y., Iitsuka T., Abe T. Metabolism of administered triethylene tetramine dihydrochloride in humans. Life Sci. 1997 ; 61: 899-907.
7. Gibbs KR, Walshe LM Orphan diseases and orphan drugs. In: Scheinberg IH, Walshe JM, eds. Orphan Diseases and Orphan Drugs. Manchester University Press ; 1986: 33-42.
8. Lu J., Chan YK, Gamble GD, Poppitt SD, Othman AA, Cooper GJS. Triethylenetetraamine and metabolites: levels in relation to copper and zinc excretion in urine of healthy volunteers and type 2 diabetic patients. Drug Metab Dispos. 2007 ; 35: 221-227.
9. Nakano Y., Nahto H., Yoshida H., et al. Liquid chromatographic determination of triethylenetetramine in human rabbit sera based on intramolecular excimer-forming fluorescence derivatization. J Chromatogr B. 2002 ; 774: 165-172.
10. Clescerl LS, Greenberg AE, Eaton AD Standard Methods for the Examination of Water and Waste Water. 20 th ed. Washington, DC: American Public Health Association ; 1998.
11. Gibaldi M., Perrier D. Pharmacokinetics. 2 nd ed. New York: Marcel Dekker ; 1982.
12. WinNonlin Professional. Mountain View, CA: Pharsight Corp ; 1998.
13. Beal SL, Sheiner LB The NONMEM system. Am Stat. 1980 ; 34: 118-119.
14. Mager DE, Wyska E., Jusko WJ Diversity of mechanism based pharmacodynamic models. Drug Metab Dispos. 2003 ; 31: 510-518.
15. Cockcroft DW, Gault MH Prediction of creatinine clearance from serum creatinine. Nephron. 1976 ; 16: 31-41.