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

NCT00964262 | Completed Phase 1 DMC

• 1 other identifier: PepE01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetes; exenatide; SR exenatide; Peptron

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and pharmacokinetics of SR exenatide (PT302) in healthy subjects after a single subcutaneous injection

  8 weeks

Secondary Outcomes (1)

• To examine the effect on glucose control and pharmacodynamic parameters of SR exenatide (PT302) in healthy subjects after a single subcutaneous injection

  8 weeks

Study Arms (1)

SR Exenatide (PT302)

EXPERIMENTAL

Intervention: Drug: SR Exenatide (PT302)

Drug: SR Exenatide (PT302); Drug: Placebo

Interventions

SR Exenatide (PT302) DRUG

0.5 mg, 1.0 mg, 2.0 mg and 4.0 mg dosage(dose escalation), single subcutaneous injection

SR Exenatide (PT302)

Placebo DRUG

Plcacebo of each doasage, single subcutanoeus injection

SR Exenatide (PT302)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects aged 20-45 years at screening
• Body weight over 50 kg, inclusive, and within 20% of ideal body weight

You may not qualify if:

• 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

Sponsors & Collaborators

• Peptron, Inc.: lead

Study Sites (1)

Clinical Trials Center, Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

• Gu N, Cho SH, Kim J, Shin D, Seol E, Lee H, Lim KS, Shin SG, Jang IJ, Yu KS. Pharmacokinetic properties and effects of PT302 after repeated oral glucose loading tests in a dose-escalating study. Clin Ther. 2014 Jan 1;36(1):101-14. doi: 10.1016/j.clinthera.2013.12.002. Epub 2013 Dec 27.

  PMID: 24373998 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kyung-Sang Yu, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2009
• First Posted: August 24, 2009
• Study Start: August 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: July 19, 2013

Record last verified: 2013-05

Locations

KR (1)