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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.
EP01572 willbe given orally to 36 male subjects; the treatment will consist of one oral dose of either EP01572 or placebo (0.005, 0.05 and 0.5 mg/kg body weight). Subjects will receive one dose of EP01572 and placebo. Six subjects will receive two additional oral doses of EP01572: 0.125 and 0.25 mg/kg body weight. In another part, 6 subjects will receive the following treatments in a randomized order: 1) administration of a bolus of saline (placebo) to the small intestine; 2) intraduodenal (ID) administration of a bolus of EP01572 at 0.2 mg/kg body weight; 3) ID perfusion of a bolus of EP01572 at 0.35 mg/kg body weight; 4) ID perfusion of a bolus of EP01572 at 0.5 mg/kg body weight.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EP1572 (ghrelin agonist) oral and duodenal application | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Growth hormone release | ||
| Pharmacokinetics |
| Measure | Description | Time Frame |
|---|---|---|
| Safety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Beglinger | University Hospital, 4031 Basel Switzerland | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17284637 | Result | 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. |
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| ID | Term |
|---|---|
| C582727 | macimorelin |
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