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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01156779
Recruitment Status : Completed
First Posted : July 5, 2010
Last Update Posted : August 13, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Drug: SR-exenatide Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2010
Primary Completion Date : April 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Assessment of safety [ Time Frame: 84 days ]
    1. Adverse Events
    2. Laboratory Results
    3. Vital sign, Physical Examination, EKG


Secondary Outcome Measures :
  1. Pharmacokinetics and Pharmacodynamics [ Time Frame: PK : 84 days / PD : 42days ]
    PK : Cmax, Tmax, AUClast PD : Glucose, Insulin, Glucagon, C-peptide in blood sample


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01156779


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

Responsible Party: Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01156779     History of Changes
Other Study ID Numbers: DA3091_DM_I
First Posted: July 5, 2010    Key Record Dates
Last Update Posted: August 13, 2013
Last Verified: August 2013

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

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