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Completed

NCT Number: NCT00377377

Oral Ghrelin Agonist in Healthy Subjects

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.

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Key information

Conditions

Healthy Subjects

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy males

Exclusion criteria

  • Females

Treatment and study plan

EP1572 (ghrelin agonist) oral and duodenal application

Drug

Primary outcomes

  1. Growth hormone release

  2. Pharmacokinetics

Secondary outcomes

  1. Safety

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Pharmacokinetics and Pharmacodynamic Effects of an Oral Ghrelin Agonist in Healthy Subjects

Important dates

Study start
2005
Study completion
2006
First posted
Sep 18, 2006
Registry last updated
May 3, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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