Type 2 Diabetes Mellitus
Conditions
Keywords
diabetes, exenatide, SR exenatide, Peptron
Brief summary
The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of SR exenatide (PT302) in healthy subjects.
Interventions
DRUGSR Exenatide (PT302)
0.5 mg, 1.0 mg, 2.0 mg and 4.0 mg dosage(dose escalation), single subcutaneous injection
DRUGPlacebo
Plcacebo of each doasage, single subcutanoeus injection
Sponsors
Peptron, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and pharmacokinetics of SR exenatide (PT302) in healthy subjects after a single subcutaneous injection | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| To examine the effect on glucose control and pharmacodynamic parameters of SR exenatide (PT302) in healthy subjects after a single subcutaneous injection | 8 weeks |
Countries
South Korea
Outcome results
None listed