Pharmacokinetic-pharmacodynamic modeling of ipamorelin, a growth hormone releasing peptide, in human volunteers

Pharmaceutical Research

Volumn 16, Issue 9, 1999, Pages 1412-1416

  Gobburu, Jogarao V S ^a,c   Agersø, Henrik ^b   Jusko, William J ^a   Ynddal, Lars ^b  

^a UNIVERSITY AT BUFFALO   (United States)

^b NOVO NORDISK A S   (Denmark)

^c CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Growth hormone releasing peptide (GHRP); Indirect response model; Ipamorelin; Population pharmacokinetics pharmacodynamics

Indexed keywords

GROWTH HORMONE; GROWTH HORMONE RELEASING FACTOR; IPAMORELIN; UNCLASSIFIED DRUG;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSAGE FORM; DRUG HALF LIFE; DRUG MECHANISM; GROWTH HORMONE RELEASE; HORMONE BLOOD LEVEL; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MALE; NORMAL HUMAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STEADY STATE;

ADULT; DOSE-RESPONSE RELATIONSHIP, DRUG; HORMONES; HUMAN GROWTH HORMONE; HUMANS; INJECTIONS, INTRAVENOUS; MALE; MODELS, BIOLOGICAL; OLIGOPEPTIDES; PREDICTIVE VALUE OF TESTS;

EID: 0032872444     PISSN: 07248741     EISSN: None     Source Type: Journal    
DOI: 10.1023/A:1018955126402     Document Type: Article

References (17)

1. B. M. Lippe and J. M. Nakamoto. Conventional and nonconventional uses of growth hormone. Recent Prog. Horm. Res. 48:179-235 (1993).
2. K. K. Ho, A. J. O'Sullivan, and D. M. Hoffman. Metabolic actions of growth hormone in man. Endocr. J. 43:S57-63 (1996).
3. M. Oyarzabal, M. Aliaga, M. Chueca, G. Echarte, and A. Ulied. Multicentre survey on compliance with growth hormone therapy: what can be improved? Acta. Paediatr. 87:387-391 (1998).
4. C. Pintor, S. Loche, R. Puggioni, S. G. Cella, V. Locatelli, A. Lampis, and E. E. Muller. Growth hormone deficiency states: approach by CNS-acting compounds. In Advances in Growth Hormone and Growth Factor Research, eds. E.E. Muller, D. Cocchi, and V. Locatelli, pp. 375-388, Pythogora press, Springer-Verlag, Berlin-Heidelberg, Germany (1989).
5. C. Y. Bowers. GH releasing peptides-structure and kinetics. J. Pediatr. Endocrinol. 6:21-31 (1993).
6. M. Ankersen, N. L. Johansen, K. Madsen, B. S. Hansen, K. Raun, K. K. Nielsen, H. Thogersen, T. K. Hansen, B. Peschke, J. Lau, B. F. Lundt, and P. H. Andersen. A new series of highly potent growth hormone-releasing peptides derived from ipamorelin. J. Med. Chem. 41:3699-3704 (1998).
7. R. Smith; L. H. T. Van der Ploeg, A. D. Howard, S. D. Feighner, K. Cheng, G. J. Hickey, M. J. Wyvratt, M. H. Fisher, R. P. Nargund, and A. A. Patchett. Peptidomimetic regulation of growth hormone secretion. Endocrinol. Rev. 5:621-645 (1997).
8. C. Y. Bowers, G. A. Reynolds, D. Durham, C. M. Barrera, S. S. Pezzoli, and M. O. Thorner. Growth hormone (GH)-releasing peptide stimulates GH release in normal men and acts synergistically with GH-releasing hormone. J. Clin. Endocrinol. Metab. 70:975-982 (1990).
9. P. B. Johansen, K. T. Hansen, J. V. Andersen, and N. L. Johansen. Pharmacokinetic evaluation of ipamorelin and other peptidyl growth hormone secretagogues with emphasis on nasal absorption. Xenobiotica 28:1083-1092 (1998).
10. S. L. Beal, L. B. Sheiner, editors. NONMEM user's guide. San Francisco, CA: NONMEM Project Group, University of California; 1992.
11. N. L. Dayneka, V. Garg, and W. J. Jusko. Comparison of four basic models of indirect pharmacodynamic responses, J. Pharmacokin. Biopharm. 24:457-478 (1993).
12. C. Pihoker, G. L. Kearns, D. French, and C. Y. Bowers. Pharmacokinetics and pharmacodynamics of growth hormone-releasing peptide-2: A phase I study in children. J. Clin. Endocrinol. Metab. 83:1168-1172 (1998).
13. S. S. Hong, P. Veng-Pedersen, H. Agersoe, and L. Yndal. Semiparametric pharmacodynamic (PD) modeling of biocompound stimulation drugs. PD of a new human growth hormone releasing peptide (GHR). Pharm. Sci. Suppl. 1:S-236 (1998).
14. K. Friend, A. Iranmanesh, and J. D. Veldhuis. The orderliness of the growth hormone (GH) release process and the mean mass of GH secreted per burst are highly conserved in individual men on successive days. J. Clin. Endocrinol. Metab. 81:3746-3753 (1996).
15. J. D. Veldhuis, M. L. Carlson, and M. L. Johnson. The pituitary gland secretes in bursts: appraising the nature of glandular secretory impulses by simultaneous multiple-parameter deconvolution of plasma hormone concentrations. Proc. Natl. Acad. Sci. USA 84:7686-7690 (1987).
16. W. K. DeBell, S. S. Pezzoli, and M. O. Thorner. Growth hormone (GH) secretion during continuous infusion of GH-releasing peptide: partial response attenuation. J. Clin. Endocrinol. Metab. 72:1312-1316 (1991).
17. K. Raun, B. S. Hansen, N. L. Johansen, H. Thogersen, K. Madsen, M. Ankersen, and P. H. Andersen. Ipamorelin, the first selective growth hormone secretagogue. Eur. J. Endocrin. 139:552-561 (1998).