Title
A Study to Evaluate Safety and Pharmacokinetics/Pharmacodynamics of Sustained Release(SR) Exenatide
A Dose Block-randomized, Double-blind, Placebo-controlled, Dose-escalating Study to Evaluate Safety and Pharmacokinetics/Pharmacodynamics of SR Exenatide (PT302) After Subcutaneous Injection in Healthy Male Volunteers
Phase
Phase 1Lead Sponsor
Peptron, Inc.Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Type 2 Diabetes MellitusIntervention/Treatment
exenatide ...Study Participants
34The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of SR exenatide (PT302) in healthy subjects.
0.5 mg, 1.0 mg, 2.0 mg and 4.0 mg dosage(dose escalation), single subcutaneous injection
Plcacebo of each doasage, single subcutanoeus injection
Intervention: Drug: SR Exenatide (PT302)
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
