Pegylated long-acting human growth hormone is well-tolerated in healthy subjects and possesses a potential once-weekly pharmacokinetic and pharmacodynamic treatment profile

Journal of Clinical Endocrinology and Metabolism

Volumn 95, Issue 7, 2010, Pages 3411-3417

  Rasmussen, Michael Højby ^a   Bysted, Britta V ^a   Anderson, Thomas W ^a   Klitgaard, Thomas ^a   Madsen, Jesper ^a  

^a NOVO NORDISK A S   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

GROWTH HORMONE BINDING PROTEIN; HUMAN GROWTH HORMONE; NEUTRALIZING ANTIBODY; NNC 126 0083; PLACEBO; RECOMBINANT GROWTH HORMONE; SIMPLEXX; SOMATOMEDIN BINDING PROTEIN; SOMATOMEDIN C; UNCLASSIFIED DRUG; DRUG DERIVATIVE; RECOMBINANT PROTEIN; SOMATOMEDIN BINDING PROTEIN 3;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; AREA UNDER THE CURVE; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BLOOD ANALYSIS; BLOOD PRESSURE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE ESCALATION; DRUG HALF LIFE; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; EDEMA; ELECTROCARDIOGRAM; EVALUATION; GLUCOSE BLOOD LEVEL; HEADACHE; HUMAN; HUMAN EXPERIMENT; IMMUNOASSAY; INJECTION SITE REACTION; INJECTION SITE TENDERNESS; INSULIN BLOOD LEVEL; MALE; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; MORNING DOSAGE; NORMAL HUMAN; PHOSPHATE BLOOD LEVEL; POTASSIUM BLOOD LEVEL; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINGLE DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION; UREA BLOOD LEVEL; ANALYSIS OF VARIANCE; BLOOD; DRUG ADMINISTRATION; ENZYME LINKED IMMUNOSORBENT ASSAY; METABOLISM; PHASE 1 CLINICAL TRIAL;

ADULT; ANALYSIS OF VARIANCE; AREA UNDER CURVE; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; ENZYME-LINKED IMMUNOSORBENT ASSAY; HUMAN GROWTH HORMONE; HUMANS; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3; INSULIN-LIKE GROWTH FACTOR I; MALE; RECOMBINANT PROTEINS;

EID: 77954900288     PISSN: 0021972X     EISSN: 0021972X     Source Type: Journal    
DOI: 10.1210/jc.2009-2813     Document Type: Article

References (18)

1. Richmond EJ, Rogol AD 2008 Growth hormone deficiency in children. Pituitary 11:115-120
2. Molitch ME, Clemmons DR, Malozowski S, Merriam GR, Shalet SM, Vance ML, Stephens PA 2006 Evaluation and treatment of adult growth hormone deficiency: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab 91:1621-1634
3. Webster R, Xie R, Didier E, Finn R, Finnessy J, Edgington A, Walker D 2008 Pegylation of somaropin (recombinant human growth hormone): impact on its clearance in humans. Xenobiotica 38:1340-1351
4. Hukshorn CJ, Saris WH, Westerterp-Plantenga MS, Farid AR, Smith FJ, Campfield LA 2000 Weekly subcutaneous pegylated recombinant native human leptin (PEG-OB) administration in obese men. J Clin Endocrinol Metab 85:4003-4009
5. Reddy KR, Wright TL, Pockros PJ, Shiffman M, Everson G, Reindollar R, Fried MW, Purdum 3rd PP, Jensen D, Smith C, Lee WM, Boyer TD, Lin A, Pedder S, DePamphilis J 2001 Efficacy and safety of pegylated (40-kd) interferon α-2a compared with interferon α-2a in noncirrhotic patients with chronic hepatitis C. Hepatology 33:433-438
6. Westerterp-Plantenga MS, Saris WH, Hukshorn CJ, Campfield LA 2001 Effects of weekly administration of pegylated recombinant human OB protein on appetite profile and energy metabolism in obese men. Am J Clin Nutr 74:426-434
7. Matthews SJ, McCoy C 2004 Peginterferon alfa-2a: a review of approved and investigational uses. Clin Ther 26:991-1025
8. Webster R, Didier E, Harris P, Siegel N, Stadler J, Tilbury L, Smith D 2007 Pegylated proteins: evaluation of their safety in the absence of definitive metabolism studies. Drug Metab Dispos 35:9-16
9. 2004 Declaration of Helsinki. Ethical principles for medical research involving human subjects. 52nd WMA General Assembly, Edinburgh, Scotland, October 2000. Last amended with note of clarification on paragraph 29 by the WMA General Assembly, Washington DC, 2002, and note of clarification on paragraph 30 by the WMA General assembly, Tokyo 2004. Ferney-Voltaire, France: World Medical Association
10. 1996 International Conference on Harmonisation, harmonised tripartite guideline: guideline for good clinical practice E6 (R1). September 4, 1996, ICH Secretariat, Geneva, Switzerland
11. Smith SL, Hindmarsh PC, Brook CG 1993 Compliance with growth hormone treatment - are they getting it? Arch Dis Child 68:91-93
12. Desrosiers P, O'Brien F, Blethen S 2005 Patient outcomes in the GH-Monitor: the effect of delivery device on compliance and growth. Pediatr Endocrinol Rev 2(Suppl 3):S327-S331
13. Rosenfeld RG, Bakker B 2008 Compliance and persistence in paediatric and adult patients receiving growth hormone therapy. Endocr Pract 14:143-154
14. Touraine P, D'Souza GA, Kourides I, Abs R, Barclay P, Xie R, Pico A, Torres-Vela E, Ekman B 2009 Lipoatrophy in GH deficient patients treated with a long-acting pegylated GH. Eur J Endocrinol 161:533-540
15. Silverman BL, Blethen SL, Reiter EO, Attie KM, Neuwirth RB, Ford KM 2002 A long-acting human growth hormone (Nutropin Depot): efficacy and safety following two years of treatment in children with growth hormone deficiency. J Pediatr Endocrinol Metab 15(Suppl 2):S715-S722
16. Reiter EO, Attie KM, Moshang Jr T, Silverman BL, Kemp SF, Neuwirth RB, Ford KM, Saenger P 2001 A multicenter study of the efficacy and safety of sustained release GH in the treatment of naive pediatric patients with GH deficiency. J Clin Endocrinol Metab 86: 4700-4706
17. Porter CJ, Edwards GA, Charman SA 2001 Lymphatic transport of proteins after s.c. injection: implications of animal model selection. Adv Drug Deliv Rev 50:157-171
18. Frystyk J 2004 Free insulin-like growth factors - measurements and relationships to growth hormone secretion and glucose homeostasis. Growth Horm IGF Res 14:337-375