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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peptron, Inc.
ClinicalTrials.gov Identifier:
NCT00964262
First received: August 21, 2009
Last updated: July 18, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: SR Exenatide (PT302)
Drug: Placebo
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Peptron, Inc.:

Primary Outcome Measures:
  • To evaluate the safety and pharmacokinetics of SR exenatide (PT302) in healthy subjects after a single subcutaneous injection [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To examine the effect on glucose control and pharmacodynamic parameters of SR exenatide (PT302) in healthy subjects after a single subcutaneous injection [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: August 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SR Exenatide (PT302)
Intervention: Drug: SR Exenatide (PT302)
Drug: SR Exenatide (PT302)
0.5 mg, 1.0 mg, 2.0 mg and 4.0 mg dosage(dose escalation), single subcutaneous injection
Drug: Placebo
Plcacebo of each doasage, single subcutanoeus injection

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00964262

Locations
Korea, Republic of
Clinical Trials Center, Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Peptron, Inc.
Investigators
Principal Investigator: Kyung-Sang Yu, MD, PhD Seoul National University Hospital
  More Information

No publications provided by Peptron, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peptron, Inc.
ClinicalTrials.gov Identifier: NCT00964262     History of Changes
Other Study ID Numbers: PepE01
Study First Received: August 21, 2009
Last Updated: July 18, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Peptron, Inc.:
diabetes
exenatide
SR exenatide
Peptron

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Exenatide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014