Oral Ghrelin Agonist in Healthy Subjects
May 2, 2007 updated by: University Hospital, Basel, Switzerland
Pharmacokinetics and Pharmacodynamic Effects of an 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment
42
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy males
Exclusion Criteria:
- Females
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Pharmacokinetics
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Growth hormone release
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Secondary Outcome Measures
Outcome Measure |
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Safety
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Christoph Beglinger, University Hospital, 4031 Basel Switzerland
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Study Completion (Actual)
July 1, 2006
Study Registration Dates
First Submitted
September 15, 2006
First Submitted That Met QC Criteria
September 15, 2006
First Posted (Estimate)
September 18, 2006
Study Record Updates
Last Update Posted (Estimate)
May 3, 2007
Last Update Submitted That Met QC Criteria
May 2, 2007
Last Verified
July 1, 2006
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EKBB 67/04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.