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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00964262
Recruitment Status : Completed
First Posted : August 24, 2009
Last Update Posted : July 19, 2013
Sponsor:
Information provided by (Responsible Party):
Peptron, Inc.

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : August 2009
Primary Completion Date : October 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. To evaluate the safety and pharmacokinetics of SR exenatide (PT302) in healthy subjects after a single subcutaneous injection [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 24, 2009    Key Record Dates
Last Update Posted: July 19, 2013
Last Verified: May 2013

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

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