The pharmacokinetics, pharmacodynamics, safety and tolerability of a single dose of NN703, a novel orally active growth hormone secretagogue in healthy male volunteers

Zdravković, Milan; Søgaard, Birgitte; Ynddal, Lars; Christiansen, Tina; Agersø, Henrik; Thomsen, M.S.; Falch, J.; Ilondo, M M

doi:10.1054/ghir.2000.0152

Cited by 21 publications

(14 citation statements)

References 11 publications

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“…Another approach to avoid the needle injections has been the development of oral available growth hormone secretagogues, [6][7][8][9] which, however, will be of sure value only in patients with a hypothalamic rather than a pituitary cause of GH deficiency. Despite promising results, none of these products are currently available on the market.…”

confidence: 99%

No Effect of the Novel Antidiabetic Agent Nateglinide on the Pharmacokinetics and Anticoagulant Properties of Warfarin in Healthy Volunteers

Anderson¹,

Shelley²,

Crick³

et al. 2002

The Journal of Clinical Pharma

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The novel hypoglycemic agent nateglinide is pharmacologically distinct from oral hypoglycemic agents such as sulfonylureas and repaglinide. The present study investigated the effects in healthy volunteers of multiple doses of nateglinide on the pharmacokinetics and pharmacodynamics of warfarin. The study comprised a randomized two-group, two-way crossover, open-label design in 12 healthy male subjects. One group of 6 subjects initially received a single oral dose of warfarin 30 mg and then, after a 7- to 14-day washout, received both warfarin and nateglinide (120 mgnateglinide, 10 min before meals for 4 days and a single dose of 30 mg warfarin on the second day). The alternate group of 6 subjects received treatments in the opposite order. Pharmacokinetic profiles were derived from plasma warfarin and nateglinide concentrations. Prothrombin measurements were evaluated in both periods as a measure of warfarin activity. When administered alone or in combination, there were no statistically significant differences in mean warfarin (R- and S-enantiomers) or nateglinide pharmacokinetic parameters. The concurrent administration of nateglinide and warfarin did not affect the maximal change in prothrombin time that follows warfarin administration. In this study, there was no evidence of an effect of coadministration of nateglinide on the pharmacodynamic action of warfarin or any pharmacokinetic interaction between warfarin and nateglinide.

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confidence: 99%

No Effect of the Novel Antidiabetic Agent Nateglinide on the Pharmacokinetics and Anticoagulant Properties of Warfarin in Healthy Volunteers

Anderson¹,

Shelley²,

Crick³

et al. 2002

The Journal of Clinical Pharma

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“…NN703 did not affect the release of prolactin, ACTH, TSH, FSH and LH. Similarly, previous studies in experimental animals (Sehested Hansen et al ., 1999) and in healthy humans (Zdravkovic et al ., 2000) have found a selective GH response after NN703 administration. However, a large proportion (74 out of 83) of NN703‐treated patients had additional hormone deficiencies that might explain the lack of effect on other pituitary hormones, especially ACTH.…”

Section: Discussionmentioning

confidence: 99%

Oral administration of the growth hormone secretagogue NN703 in adult patients with growth hormone deficiency

Svensson

Monson

Vetter

et al. 2003

Clinical Endocrinology

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NN703 administration was generally well tolerated. Eleven per cent of the GHD adult patients responded with a peak GH response >or= 5 micro g/l after the first and/or last administration of oral NN703. Although a majority of GHD adults will not respond to NN703, the present results suggest that oral NN703 treatment could be useful in some adult patients with moderately severe GHD. These patients may be identified by a test dose of GHS.

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“…Other ghrelin mimetic compounds are in the early stage of testing and have shown GH releasing effects in healthy adults, supporting a role for ghrelin mimetics also as a potential diagnostic tool to be used in the future in diagnosing GH deficiency (Zdravkovic et al 2000). …”

Section: Potential Use Of Ghrelin or Ghrelin Antagonists In Diseasementioning

confidence: 99%

The ghrelin axis in disease: Potential therapeutic indications

Nass

Gaylinn

Thorner

2011

Molecular and Cellular Endocrinology

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Ghrelin, the natural ligand for the growth hormone (GH)-secretagogue receptor (GHS-R), is produced predominantly in the stomach. It is present in the circulation in two major forms, an acylated and an unacylated form, both of which have reported activities. Some of the best understood main effects of acylated ghrelin administration include anorexic effects, increased appetite and the stimulation of GH secretion. Ghrelin also seems to plays a role in glucose homeostasis, lipid metabolism and immune function. Based on its orexigenic and metabolic effects, ghrelin and ghrelin mimetics have potential benefit in antagonizing protein breakdown and weight loss in catabolic conditions such as cancer cachexia, renal, cardiac and pulmonary disease, and age-related frailty. Ghrelin also has potentially useful positive effects on cardiac function and gastric motility. Ghrelin antagonists may be of benefit to increase insulin sensitivity and potentiate weight loss. The following chapter presents some background on ghrelin and ghrelin assays and discusses some of the potential therapeutic approaches for the use of ghrelin, ghrelin mimetic compounds and ghrelin antagonists in clinical disease.

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The pharmacokinetics, pharmacodynamics, safety and tolerability of a single dose of NN703, a novel orally active growth hormone secretagogue in healthy male volunteers

Cited by 21 publications

References 11 publications

No Effect of the Novel Antidiabetic Agent Nateglinide on the Pharmacokinetics and Anticoagulant Properties of Warfarin in Healthy Volunteers

No Effect of the Novel Antidiabetic Agent Nateglinide on the Pharmacokinetics and Anticoagulant Properties of Warfarin in Healthy Volunteers

Oral administration of the growth hormone secretagogue NN703 in adult patients with growth hormone deficiency

The ghrelin axis in disease: Potential therapeutic indications

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