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Oral Ghrelin Agonist in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT00377377
Recruitment Status : Completed
First Posted : September 18, 2006
Last Update Posted : May 3, 2007
Sponsor:
Information provided by:

Study Description
Brief 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.

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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics and Pharmacodynamic Effects of an Oral Ghrelin Agonist in Healthy Subjects
Study Start Date : November 2005
Study Completion Date : July 2006
Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Growth hormone release
  2. Pharmacokinetics

Secondary Outcome Measures :
  1. Safety

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males

Exclusion Criteria:

  • Females
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: September 18, 2006    Key Record Dates
Last Update Posted: May 3, 2007
Last Verified: July 2006

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