Status:
COMPLETED
Effects of Exendin(9-39) on Gastroduodenal Motility
Lead Sponsor:
Ludwig-Maximilians - University of Munich
Collaborating Sponsors:
German Research Foundation
Philipps University Marburg
Conditions:
Digestive Physiology
Gastrointestinal Motility
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study in humans is to define the effects of the endogenous hormone GLP-1 on gastroduodenal motility and on endocrine pancreatic secretion by using the specific GLP-1 receptor antag...
Detailed Description
Following a meal, gut-produced incretin hormones such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are released into the circulation. GLP-1 and GIP, the tw...
Eligibility Criteria
Inclusion
- Male or female (postmenopausal, surgically sterile or using double-barrier method of contraception) healthy volunteers
- Age 18-65 years
- Body mass index (BMI) \< 30 kg/m2
- Must have a fasting blood glucose below 100 mg/dl at screening and on all study days
- Able to provide written informed consent prior to study participation
- Able to communicate well with the investigator and comply with the requirements of the study
Exclusion
- Diabetes mellitus
- Treatment with systemic steroids and thyroid hormone
- Patients with any history of gastrointestinal surgery, e.g. partial bowel resections, partial gastric resections, etc.
- Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
- Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
- Significant illness within the two weeks prior to dosing.
- Past medical history of clinically significant electrocardiogram (ECG) abnormalities or a family history of a prolonged QT-interval syndrome.
- History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug.
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the subject in case of participation in the study. The investigator should be guided by evidence of any of the following:
- history of inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or rectal bleeding
- history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
- history or clinical evidence of pancreatic injury or pancreatitis
Key Trial Info
Start Date :
February 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2000
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00468091
Start Date
February 1 1999
End Date
September 1 2000
Last Update
April 1 2015
Active Locations (1)
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1
Clinical Research unit, Dept. of Internal Medicine II - Großhadern, University of Munich
Munich, Germany, 81377