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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Completion Date :||February 2007|
- Plasma concentrations of GLP-1 and PYY3-36
- Effect on ghrelin secretion
- Effect on insulin (GLP-1 only)
- Adverse events
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
|Clinical Research Centre, University Hospital|
|Basel, Switzerland, CH-4031|
|Principal Investigator:||Christoph Beglinger, MD||University Hospital, 4031 Basel, Switzerland|