Oral Administration of Peptides; Absorption From Gastrointestinal Tract

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

Tracking Information

• First Submitted Date: May 2, 2007
• First Posted Date: May 3, 2007
• Last Update Posted Date: October 17, 2008
• Study Start Date: October 2006
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: May 2, 2007): Plasma concentrations of GLP-1 and PYY3-36
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 2, 2007)

• Effect on ghrelin secretion
• Effect on insulin (GLP-1 only)
• Adverse events

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Oral Administration of Peptides; Absorption From Gastrointestinal Tract
• Official Title: Pharmacokinetics and Pharmacodynamic Effects of Oral GLP-1 and PYY3-36: a Proof of Concept Study in Healthy Subjects

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.

• 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 Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Healthy

Intervention

• Drug: Increasing doses of GLP-1
• Drug: PYY3-36

• Study Arms: Not Provided
• Publications *: Degen L, Oesch S, Casanova M, Graf S, Ketterer S, Drewe J, Beglinger C. Effect of peptide YY3-36 on food intake in humans. Gastroenterology. 2005 Nov;129(5):1430-6.

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: May 2, 2007): 12
• Original Enrollment: Same as current
• Actual Study Completion Date: February 2007
• Primary Completion Date: Not Provided

Eligibility Criteria

Inclusion Criteria:

• healthy males

Exclusion Criteria:

• females

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT00468884
• Other Study ID Numbers: Oral GLP-1 and PYY
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital, Basel, Switzerland
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Christoph Beglinger, MD; University Hospital, 4031 Basel, Switzerland

• PRS Account: University Hospital, Basel, Switzerland
• Verification Date: October 2008