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| Sponsored by: |
University Hospital, Basel, Switzerland |
|---|---|
| Information provided by: | University Hospital, Basel, Switzerland |
| ClinicalTrials.gov Identifier: | NCT00468884 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Increasing doses of GLP-1 Drug: PYY3-36 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Placebo Control, Single Group Assignment, Pharmacokinetics/Dynamics Study |
| Official Title: | Pharmacokinetics and Pharmacodynamic Effects of Oral GLP-1 and PYY3-36: a Proof of Concept Study in Healthy Subjects |
| Estimated Enrollment: | 12 |
| Study Start Date: | October 2006 |
| Study Completion Date: | February 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria: - healthy males Exclusion Criteria: - females
Contacts and Locations| Switzerland | |
| Clinical Research Centre, University Hospital | |
| Basel, Switzerland, CH-4031 | |
| Principal Investigator: | Christoph Beglinger, MD | University Hospital, 4031 Basel, Switzerland |
More Information
| Study ID Numbers: | Oral GLP-1 and PYY |
| Study First Received: | May 2, 2007 |
| Last Updated: | October 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00468884 History of Changes |
| Health Authority: | Switzerland: Ethikkommission |
|
Kinetics of GLP-1 and PYY3-36; increasing oral doses |
|
Healthy Glucagon-Like Peptide 1 |
