Study to Evaluate Safety and PK/PD of DA-3091 in Healthy Male Subjects (SR-Exenatide)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01156779
First received: July 2, 2010
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

This Phase I clinical study is to evaluate the safety and tolerance of DA-3091 and to characterize the pharmacokinetic/pharmacodynamic of DA-3091 in healthy male subjects


Condition Intervention Phase
Diabetes Mellitus
Drug: SR-exenatide
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Dose Block-randomized, Double-blind, Placebo-controlled, Dose-escalating, Phase I Study to Evaluate Safety and Pharmacokinetics/Pharmacodynamics of DA-3091 After Subcutaneous Injection in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by Dong-A ST Co., Ltd.:

Primary Outcome Measures:
  • Assessment of safety [ Time Frame: 84 days ] [ Designated as safety issue: No ]
    1. Adverse Events
    2. Laboratory Results
    3. Vital sign, Physical Examination, EKG


Secondary Outcome Measures:
  • Pharmacokinetics and Pharmacodynamics [ Time Frame: PK : 84 days / PD : 42days ] [ Designated as safety issue: No ]
    PK : Cmax, Tmax, AUClast PD : Glucose, Insulin, Glucagon, C-peptide in blood sample


Enrollment: 31
Study Start Date: July 2010
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DA-3091
SR-exenatide
Drug: SR-exenatide
Emulsion 0.5mg,1mg,2mg,4mg dosage (Dose-escalation) Single injection
Other Name: DA-3091
Placebo Comparator: Placebo of DA-3091
Placebo
Drug: SR-exenatide
Emulsion 0.5mg,1mg,2mg,4mg dosage (Dose-escalation) Single injection
Other Name: DA-3091

Detailed Description:

This is a phase I dose escalation study. To meet the clinical objectives, we are using a two-part approach. In part I, 4 subjects are injected 0.5mg dose of DA-3091 or placebo(Single/Subcutaneous Injection). After completion of part I study, we are reporting data about safety to IDMC. In part II, 8 subjects per group are injected 1mg, 2mg, 4mg of DA-3091 or placebo through dose escalating protocol. The ratio of DA-3091 and placebo is 3:1.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age : 20 ~ 45 years old
  2. Healthy Male
  3. Body weight : ≥50kg and Ideal body weight ± 20%
  4. Informed consent

Exclusion Criteria:

  1. Clinically significant medical history
  2. Acute or Chronic pancreatitis
  3. Clinically significant hypersensitivity of Drugs
  4. Clinically significant cutaneous disorder
  5. History of administration of exenatide
  6. Disorder of blood pressure
  7. History of drug abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156779

Locations
Korea, Republic of
Clinical Trial center, Clinical Research institute, Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Dong-A ST Co., Ltd.
Investigators
Principal Investigator: Kyung-Sang Yu, M.D., Ph.d Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT01156779     History of Changes
Other Study ID Numbers: DA3091_DM_I
Study First Received: July 2, 2010
Last Updated: August 12, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Dong-A ST Co., Ltd.:
SR-Exenatide

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Exenatide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014