Status:
COMPLETED
A Study to Evaluate Safety and Pharmacokinetics/Pharmacodynamics of Sustained Release(SR) Exenatide
Lead Sponsor:
Peptron, Inc.
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of SR exenatide (PT302) in healthy subjects.
Eligibility Criteria
Inclusion
- Healthy male subjects aged 20-45 years at screening
- Body weight over 50 kg, inclusive, and within 20% of ideal body weight
Exclusion
- Has a present illness or medical history of hepatic, renal, respiratory, cardiovascular disease, blood tumor, mental disorder, and endocrinologic disorder, especially diabetes mellitus
- Has a sign or symptom or history related to an acute or chronic pancreatitis
- Has a known allergy or hypersensitivity to exenatide or other drugs such as aspirin, antibiotics, and so on
- Has ever been exposed to exenatide
- Shows SBP \>= 150 mmHg or \<= 90 mmHg or DBP \>= 100 mmHg or \<= 50 mmHg
- Has a presence or history of drug abuse
- Uses any prescription drug, herbal medicine within 2 weeks or OTC drugs or vitamin within 1 week prior to study drug administration
- Has been participated in other clinical trial within 2 months
- Has experience of a blood donation during 2 months or a blood transfusion during 1 month prior to study drug administration
- Heavy smoker more than 10 cigarettes/day within 3 months prior to screening
- Continuous drinker (over 21 units/week, 1 unit = 10 g of pure alcohol) or subject who can't quit drinking nor smoking during clinical trial period
- Subjects not eligible at the discretion of investigators
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00964262
Start Date
August 1 2009
End Date
October 1 2010
Last Update
July 19 2013
Active Locations (1)
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1
Clinical Trials Center, Seoul National University Hospital
Seoul, South Korea, 110-744