NCT00468884

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2007

Completed
Last Updated

October 17, 2008

Status Verified

October 1, 2008

First QC Date

May 2, 2007

Last Update Submit

October 16, 2008

Conditions

Healthy

Keywords

Kinetics of GLP-1 and PYY3-36; increasing oral doses

Outcome Measures

Primary Outcomes (1)

  • Plasma concentrations of GLP-1 and PYY3-36

Secondary Outcomes (3)

  • Effect on ghrelin secretion

  • Effect on insulin (GLP-1 only)

  • Adverse events

Interventions

Increasing doses of GLP-1DRUG
PYY3-36DRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy males

You may not qualify if:

  • females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Centre, University Hospital

Basel, CH-4031, Switzerland

Location

Related Publications (1)

  • 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. doi: 10.1053/j.gastro.2005.09.001.

    PMID: 16285944BACKGROUND

MeSH Terms

Interventions

peptide YY (3-36)

Study Officials

  • Christoph Beglinger, MD

    University Hospital, 4031 Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 2, 2007

First Posted

May 3, 2007

Study Start

October 1, 2006

Study Completion

February 1, 2007

Last Updated

October 17, 2008

Record last verified: 2008-10

Locations

CH(1)