Oral Ghrelin Agonist in Healthy Subjects

Phase 1 Completed 42 enrolled University Hospital, Basel, Switzerland

RandomizedParallel-groupOpen-labelTreatment

Summary

EP01572 is a peptidomimetic growth hormone secretagogue, which has potent GH-releasing activity after intravenous administration.It is an analogue of the natural compound ghrelin. Since an oral delivery system would be preferable in many of the possible therapeutic indications, the pharmacological profile and the GH-releasing activity of increasing single, oral doses of EP01572 in healthy volunteers will be evaluated. In addition, the pharmacokinetics and pharmacological effects of EP01572 will be investigated after intraduodenal administration.

Timeline

Start: 2005-11
Primary completion: —
Completion: 2006-07

Publications

Results Piccoli F, Degen L, MacLean C, Peter S, Baselgia L, Larsen F, Beglinger C, Drewe J. Pharmacokinetics and pharmacodynamic effects of an oral ghrelin agonist in healthy subjects. J Clin Endocrinol Metab. 2007 May;92(5):1814-20. doi: 10.1210/jc.2006-2160. Epub 2007 Feb 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Macimorelin	Small molecule	0.005 mg/kg	Oral
Subject	Macimorelin	Small molecule	0.05 mg/kg	Oral
Subject	Macimorelin	Small molecule	0.125 mg/kg	Oral
Subject	Macimorelin	Small molecule	0.2 mg/kg	Oral
Subject	Macimorelin	Small molecule	0.25 mg/kg	Oral
Subject	Macimorelin	Small molecule	0.35 mg/kg	Oral
Subject	Macimorelin	Small molecule	0.5 mg/kg	Oral

Indications

No indication recorded.