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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-10-31

Brief Summary

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

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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SR Exenatide (PT302)

Intervention: Drug: SR Exenatide (PT302)

Group Type EXPERIMENTAL

SR Exenatide (PT302)

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Plcacebo of each doasage, single subcutanoeus injection

Interventions

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SR Exenatide (PT302)

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

Intervention Type DRUG

Placebo

Plcacebo of each doasage, single subcutanoeus injection

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes