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 Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01156779
First received: July 2, 2010
Last updated: August 12, 2013
Last verified: August 2013

July 2, 2010
August 12, 2013
July 2010
April 2012   (final data collection date for primary outcome measure)
Assessment of safety [ Time Frame: 84 days ] [ Designated as safety issue: No ]
  1. Adverse Events
  2. Laboratory Results
  3. Vital sign, Physical Examination, EKG
Same as current
Complete list of historical versions of study NCT01156779 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Study to Evaluate Safety and PK/PD of DA-3091 in Healthy Male Subjects
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

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus
Drug: SR-exenatide
Emulsion 0.5mg,1mg,2mg,4mg dosage (Dose-escalation) Single injection
Other Name: DA-3091
  • Experimental: DA-3091
    SR-exenatide
    Intervention: Drug: SR-exenatide
  • Placebo Comparator: Placebo of DA-3091
    Placebo
    Intervention: Drug: SR-exenatide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
Not Provided
April 2012   (final data collection date for primary outcome measure)

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
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01156779
DA3091_DM_I
Yes
Dong-A Pharmaceutical Co., Ltd.
Dong-A Pharmaceutical Co., Ltd.
Not Provided
Principal Investigator: Kyung-Sang Yu, M.D., Ph.d Seoul National University Hospital
Dong-A Pharmaceutical Co., Ltd.
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP