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Titolo:
The pharmacokinetics, pharmacodynamics, safety and tolerability following 7 days daily oral treatment with NN703 in healthy male subjects
Autore:
Zdravkovic, M; Christiansen, T; Eliot, L; Agersoe, H; Thomsen, MS; Falch, JF; Sogaard, B; Ynddal, L; Ilondo, MM;
Indirizzi:
Novo Nordisk AS, Dept Clin Pharmacol, DK-2880 Bagsvaerd, Denmark Novo Nordisk AS Bagsvaerd Denmark DK-2880 ol, DK-2880 Bagsvaerd, Denmark Novo Nordisk AS, Dept Clin Stat, DK-2880 Bagsvaerd, Denmark Novo Nordisk AS Bagsvaerd Denmark DK-2880 at, DK-2880 Bagsvaerd, Denmark Novo Nordisk AS, Dept Pharmacokinet, DK-2760 Maalov, Denmark Novo Nordisk AS Maalov Denmark DK-2760 acokinet, DK-2760 Maalov, Denmark Novo Nordisk AS, Dept Clin Drug Dev, DK-2880 Bagsvaerd, Denmark Novo Nordisk AS Bagsvaerd Denmark DK-2880 ev, DK-2880 Bagsvaerd, Denmark
Titolo Testata:
GROWTH HORMONE & IGF RESEARCH
fascicolo: 1, volume: 11, anno: 2001,
pagine: 41 - 48
SICI:
1096-6374(200102)11:1<41:TPPSAT>2.0.ZU;2-O
Fonte:
ISI
Lingua:
ENG
Soggetto:
HORMONE (GH)-RELEASING PEPTIDE; GH SECRETAGOGUE MK-677; GROWTH-FACTOR-I; CHILDREN; RELEASE; DESENSITIZATION; PITUITARY; SECRETION; RECEPTOR; MEN;
Keywords:
NN703; growth hormone secretagogue; clinical study; tabimorelin;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Life Sciences
Citazioni:
20
Recensione:
Indirizzi per estratti:
Indirizzo: Zdravkovic, M Novo Nordisk AS, Dept Clin Pharmacol, DK-2880 Bagsvaerd, Denmark Novo Nordisk AS Bagsvaerd Denmark DK-2880 gsvaerd, Denmark
Citazione:
M. Zdravkovic et al., "The pharmacokinetics, pharmacodynamics, safety and tolerability following 7 days daily oral treatment with NN703 in healthy male subjects", GROWTH H I, 11(1), 2001, pp. 41-48

Abstract

The aim of the present study was to assess the safety, pharmacokinetics and pharmacodynamics (including specificity) of NN703 (tabimorelin), a growthhormone (GH) secretagogue, in healthy male subjects following treatment for 7 days once-daily. This was a randomized, double-blind and placebo-controlled study with four active dose levels: 1.71, 3.0, 4.5 and 6.86 mg/kg bodyweight. There was a dose-related increase for GH area under the curve (AUC) (0-12 h) and GH C-max (0-12 h); these were significantly higher on both days 1 and 7 as compared with placebo treatment (P= 0.04 to P < 0.0001); however, an overall significant decrease in GH release was found from day 1 today 7 (P < 0.001). Insulin-like growth factor-I (IGF-I) and IGF binding protein 3 (IGFBP-3) increased at all dose levels (including placebo); however, a significantly higher increase as compared with placebo treatment was observed at the three highest dose levels for IGF-I (P = 0.04-0.0006) and at the highest dose level for IGFBP-3 (P = 0.03). There was no statistically significant increase in AUC (0-5 h) for follicle-stimulating hormone, luteinizing hormone and cortisol between active and placebo treatment for day 1 or 7. On day 1 only, a statistically significant increase in AUC (0-5 h) wasfound for prolactin at 1.71 and 6.86 mg/kg (P < 0.05), for thyroid-stimulating hormone (TSH) at 3.0 mg/kg (P < 0.01) and for adrenocorticotrophic hormone (ACTH) at 4.5 mg/kg (P < 0.05); however, no dose-response relationshipwas observed for TSH or ACTH. In addition, a statistically significant decrease in AUC (0-5 h) for ACTH (3.0 and 6.86 mg/kg) and cortisol (1.71 mg/kg) was observed on day 7 (P < 0.05). Thus, NN703 is a promising candidate for treatment of absolute or relative GH deficiency. (C) 2001 Harcourt Publishers Ltd.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 11/07/20 alle ore 03:29:14