A Study to Evaluate Safety and Pharmacokinetics/Pharmacodynamics of Sustained Release(SR) Exenatide
Phase 1
Completed
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: Placebo
- Registration Number
- NCT00964262
- Lead Sponsor
- Peptron, Inc.
- Brief Summary
The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of SR exenatide (PT302) in healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 34
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SR Exenatide (PT302) Placebo Intervention: Drug: SR Exenatide (PT302) SR Exenatide (PT302) SR Exenatide (PT302) Intervention: Drug: SR Exenatide (PT302)
- Primary Outcome Measures
Name Time Method To evaluate the safety and pharmacokinetics of SR exenatide (PT302) in healthy subjects after a single subcutaneous injection 8 weeks
- Secondary Outcome Measures
Name Time Method To examine the effect on glucose control and pharmacodynamic parameters of SR exenatide (PT302) in healthy subjects after a single subcutaneous injection 8 weeks
Trial Locations
- Locations (1)
Clinical Trials Center, Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of