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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: SR Exenatide (PT302); 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

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-21
• Study First Submitted QC: 2009-08-21
• Study First Posted: 2009-08-24
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2013-05
• Last Update Submitted: 2013-07-18
• Last Update Posted: 2013-07-19

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