Clinical trial NCT00964262: A Study to Evaluate Safety and Pharmacokinetics/Pharmacodynamics of Sustained Release(SR) Exenatide
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
exenatide
SR exenatide
Peptron
Lead sponsor: Peptron, Inc.
Sponsor class: INDUSTRY
First posted: 2009-08-24
Enrollment: 34
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: To evaluate the safety and pharmacokinetics of SR exenatide (PT302) in healthy subjects after a single subcutaneous injection
timeFrame: 8 weeks
Secondary outcomes:
measure: To examine the effect on glucose control and pharmacodynamic parameters of SR exenatide (PT302) in healthy subjects after a single subcutaneous injection
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinical Trials Center, Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-Sang Yu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.