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Oral Administration of Peptides; Absorption From Gastrointestinal Tract

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ClinicalTrials.gov Identifier: NCT00468884
Recruitment Status : Completed
First Posted : May 3, 2007
Last Update Posted : October 17, 2008
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland

Study Description
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Brief Summary:

Context: Oral formulations of GLP-1 and PYY3-36, two satiety peptides, were studied. An oral delivery system would be preferable in many of the possible therapeutic indications of these peptides.

Objectives: Our objective was to establish the pharmacological profile of increasing oral doses of GLP-1 and PYY3-36 in healthy volunteers. In addition, the pharmacological effects of GLP-1 were investigated.

Setting: Single center escalating dose study with oral applications. Subjects and Methods: In the first part, GLP-1 was given orally to 6 male subjects; the treatment consisted of one of the following oral doses of either GLP-1 (0.5, 1.0, 2.0 and 4.0 mg) or placebo. In the second part, PYY3-36 was given orally to another 6 healthy male subjects; the treatment consisted of one of the following oral doses of either PYY3-36 (0.25, 0.5, 1.0, 2.0 and 4.0 mg) or placebo.


Condition or disease Intervention/treatment Phase
Healthy Drug: Increasing doses of GLP-1 Drug: PYY3-36 Phase 1

Detailed Description:
The study was conducted as a phase I, open, placebo-controlled, dose-escalating study. In part I, six treatments, separated by at least 7 days, were performed in 6 male subjects; treatments consisted of one oral dose of GLP-1(7-36 amide) (0.5, 1.0, 2.0, and 4 mg) or placebo; the last treatment was an intravenous infusion of GLP-1 given for 45 min (0.4 pmol/kg per min infused for 45 min). The treatments were identical in design except for the oral dose of GLP-1. In part II, six oral treatments, separated by at least 7 days, were given in an additional 6 male subjects; treatments consisted of one oral dose of PYY3-36 (0.25, 0.5, 1.0, 2.0, and 4 mg) or placebo; an intravenous infusion of PYY3-36 could not be given as no GMP conform PYY3-36 was available for use in humans. Blood was drawn in regular intervals in EDTA tubes containing aprotinin (500 kIU/ml blood) and a DPP-IV inhibitor for hormone determinations: -30, -15, 0, 15, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300 min.
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics and Pharmacodynamic Effects of Oral GLP-1 and PYY3-36: a Proof of Concept Study in Healthy Subjects
Study Start Date : October 2006
Actual Study Completion Date : February 2007
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Plasma concentrations of GLP-1 and PYY3-36

Secondary Outcome Measures :
  1. Effect on ghrelin secretion
  2. Effect on insulin (GLP-1 only)
  3. Adverse events

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy males

Exclusion Criteria:

  • females
Contacts and Locations
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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): NCT00468884


Locations
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Switzerland
Clinical Research Centre, University Hospital
Basel, Switzerland, CH-4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Christoph Beglinger, MD University Hospital, 4031 Basel, Switzerland
More Information
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Publications:

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ClinicalTrials.gov Identifier: NCT00468884    
Other Study ID Numbers: Oral GLP-1 and PYY
First Posted: May 3, 2007    Key Record Dates
Last Update Posted: October 17, 2008
Last Verified: October 2008
Keywords provided by University Hospital, Basel, Switzerland:
Kinetics of GLP-1 and PYY3-36; increasing oral doses