Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00468884
Status:
COMPLETED
Last Update Posted:
2008-10-17
First Post:
2007-05-02
Brief Title:
Oral Administration of Peptides Absorption From Gastrointestinal Tract
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Pharmacokinetics and Pharmacodynamic Effects of Oral GLP-1 and PYY3-36 a Proof of Concept Study in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 05 10 20 and 40 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 PYY3-36 025 05 10 20 and 40 mg or placebo
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 05 10 20 and 40 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 PYY3-36 025 05 10 20 and 40 mg or placebo
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-17-36 amide 05 10 20 and 4 mg or placebo the last treatment was an intravenous infusion of GLP-1 given for 45 min 04 pmolkg 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 PYY3-36 025 05 10 20 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 kIUml blood and a DPP-IV inhibitor for hormone determinations -30 -15 0 15 30 45 60 75 90 120 150 180 240 300 min
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None