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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00964262
• Other study ID #: PepE01
• Status: Completed
• Phase: Phase 1
• First received: August 21, 2009
• Last updated: July 18, 2013
• Start date: August 2009
• Est. completion date: October 2010

Study information

• Verified date: May 2013
• Source: Peptron, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• SR Exenatide (PT302)
0.5 mg, 1.0 mg, 2.0 mg and 4.0 mg dosage(dose escalation), single subcutaneous injection
• Placebo
Plcacebo of each doasage, single subcutanoeus injection

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trials Center, Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Peptron, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and pharmacokinetics of SR exenatide (PT302) in healthy subjects after a single subcutaneous injection		8 weeks	No
Secondary	To examine the effect on glucose control and pharmacodynamic parameters of SR exenatide (PT302) in healthy subjects after a single subcutaneous injection		8 weeks	No