A Study to Characterize the Pharmacokinetics/Pharmacodynamics and Effect of Food of DA-1229 in Healthy Male Subjects

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Dong-A Pharmaceutical Co., Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00961025
First received: August 10, 2009
Last updated: August 20, 2009
Last verified: August 2009
  Purpose

This is a dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose-escalation study. The study is designed to describe the relationship between multiple doses and pharmacokinetic/pharmacodynamic parameters of DA-1229 as well as safety profile.


Condition Intervention Phase
Diabetes Mellitis Type 2
Drug: DA-1229
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dosing, Dose Escalation Clinical Phase 1 Study to Investigate the Safety, Tolerance, and Pharmacokinetics/Pharmacodynamics of DA-1229 in Healthy Male Subjects

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

Primary Outcome Measures:
  • To characterize the pharmacokinetic/pharmacodynamic of DA-1229 in healthy male subjects [ Time Frame: Multiple blood and urine samples will be collected for 120 hours after dosing of DA-1229 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the safety and tolerance of DA-1229 [ Time Frame: up to 10 days (single dose study), 17 days (single dose study for food effect), 20 days (multiple dose study) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 110
Study Start Date: May 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
placebo
Experimental: DA-1229
DA-1229
Drug: DA-1229

single dose study : DA-1229 1.25,2.5,5,10,20,40,60mg

multiple dose study : DA-1229 5,10,20,40mg


  Eligibility

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

Inclusion Criteria:

  • 20-45 years healthy male subjects
  • Body weight :50-90kg, BMI between 18.5-25
  • Blood glucose level of 70-110mg/dL on the FPG test

Exclusion Criteria:

  • have a family history of diabetes
  • Serum AST(SGOT), ALT(SGPT)>1.25 times upper limit of normal
  • Creatinine clearance rate<80mL/min
  • show SBP =<100mmHg or >=150mmHg, or DBP=<65mmHg or >=95mmHg, or tachycardia (PR>=100times/min)
  • have a history of drug abuse or show positive for drug abuse or cotinine at urine screening
  • smokers
  • can not digest high-fat or high-calorie food(applicable only for the 10mg dose group subjects
  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: NCT00961025

Contacts
Contact: Kyung-Sang Yu, M.D., Ph.d., M.B.A. +82-2-2072-1920 ksyu@snuh.ac.kr

Locations
Korea, Republic of
Clinical Trials Center, Seoul National University Hospital Recruiting
Seoul, Chongo-Gu, Yon-Gon Dong, Korea, Republic of, 110-744
Contact: Kyung-Sang Yu, M.D., Ph.D., M.B.A    +82-2-2072-1920    ksyu@snu.ac.kr   
Principal Investigator: Kyung-Sang Yu, M.D.,Ph.D.,M.B.A.         
Sub-Investigator: In-Jin Jang, M.D.,Ph.D.         
Sponsors and Collaborators
Dong-A Pharmaceutical Co., Ltd.
  More Information

No publications provided by Dong-A Pharmaceutical Co., Ltd.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: KEUMJAE KO / Assistant Manager, Clinical Development Team 1
ClinicalTrials.gov Identifier: NCT00961025     History of Changes
Other Study ID Numbers: DA1229_DM_I
Study First Received: August 10, 2009
Last Updated: August 20, 2009
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on July 24, 2014