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Oral Ghrelin Agonist in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00377377
First received: September 15, 2006
Last updated: May 2, 2007
Last verified: July 2006
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy Subjects
 Drug: EP1572 (ghrelin agonist) oral and duodenal application
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetics and Pharmacodynamic Effects of an Oral Ghrelin Agonist in Healthy Subjects

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Growth hormone release
  • Pharmacokinetics

Secondary Outcome Measures:
  • Safety

Estimated Enrollment: 42
Study Start Date: November 2005
Study Completion Date: July 2006
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males

Exclusion Criteria:

  • Females
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00377377

Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Christoph Beglinger University Hospital, 4031 Basel Switzerland
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00377377     History of Changes
Other Study ID Numbers: EKBB 67/04
Study First Received: September 15, 2006
Last Updated: May 2, 2007
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
GH release
Pharmacokinetics
Safety

ClinicalTrials.gov processed this record on June 17, 2013