Oral Administration of Peptides; Absorption From Gastrointestinal Tract

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00468884
First received: May 2, 2007
Last updated: October 16, 2008
Last verified: October 2008
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Plasma concentrations of GLP-1 and PYY3-36

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

Estimated Enrollment: 12
Study Start Date: October 2006
Study Completion Date: February 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy males

Exclusion Criteria:

  • females
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468884

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

Publications:
ClinicalTrials.gov Identifier: NCT00468884     History of Changes
Other Study ID Numbers: Oral GLP-1 and PYY
Study First Received: May 2, 2007
Last Updated: October 16, 2008
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
Kinetics of GLP-1 and PYY3-36; increasing oral doses

ClinicalTrials.gov processed this record on July 28, 2014