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

July 18, 2013 updated by: Peptron, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Clinical trials center, Seoul national university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety and pharmacokinetics of SR exenatide (PT302) in healthy subjects after a single subcutaneous injection
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peptron, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

August 21, 2009

First Submitted That Met QC Criteria

August 21, 2009

First Posted (Estimate)

August 24, 2009

Study Record Updates

Last Update Posted (Estimate)

July 19, 2013

Last Update Submitted That Met QC Criteria

July 18, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PepE01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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