A Study to Evaluate Safety and Pharmacokinetics/Pharmacodynamics of Sustained Release(SR) Exenatide

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of SR exenatide (PT302) in healthy subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Peptron, Inc.
• Treatments: Exenatide

Criteria

Inclusion Criteria:

• Healthy male subjects aged 20-45 years at screening

• Body weight over 50 kg, inclusive, and within 20% of ideal body weight

Exclusion Criteria:

• 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