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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

August 21, 2009
July 18, 2013
August 2009
October 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00964262 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate Safety and Pharmacokinetics/Pharmacodynamics of Sustained Release(SR) Exenatide
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • 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
Experimental: SR Exenatide (PT302)
Intervention: Drug: SR Exenatide (PT302)
Interventions:
  • Drug: SR Exenatide (PT302)
  • Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00964262
PepE01
Yes
Peptron, Inc.
Peptron, Inc.
Not Provided
Principal Investigator: Kyung-Sang Yu, MD, PhD Seoul National University Hospital
Peptron, Inc.
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP