Skip to main content
OpenTrials
Completed

NCT Number: NCT00964262

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trials Center, Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SR Exenatide (PT302)

Drug

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

Placebo

Drug

Plcacebo of each doasage, single subcutanoeus injection

Primary outcomes

  1. To evaluate the safety and pharmacokinetics of SR exenatide (PT302) in healthy subjects after a single subcutaneous injection

    Time frame: 8 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Peptron, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 24, 2009
Registry last updated
Jul 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.