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
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 April 23, 2014