drugset / Trial / NCT00468884

Oral Administration of Peptides; Absorption From Gastrointestinal Tract

NCT00468884

Phase 1 Completed 12 enrolled University Hospital, Basel, Switzerland
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2006-10
Primary completion
Completion
2007-02

Drugs

EvaluationDrugModalityDoseRoute
Subject GLP-1 Peptide 0.5 mg Oral
Subject GLP-1 Peptide 1 mg Oral
Subject GLP-1 Peptide 2 mg Oral
Subject GLP-1 Peptide 4 mg Oral
Subject PEPTIDE YY HUMAN (3-36) Peptide 0.25 mg Oral
Subject PEPTIDE YY HUMAN (3-36) Peptide 0.5 mg Oral
Subject PEPTIDE YY HUMAN (3-36) Peptide 1 mg Oral
Subject PEPTIDE YY HUMAN (3-36) Peptide 2 mg Oral
Subject PEPTIDE YY HUMAN (3-36) Peptide 4 mg Oral

Indications

No indication recorded.