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

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ClinicalTrials.gov Identifier: NCT00961025
Recruitment Status : Unknown
Verified August 2009 by Dong-A ST Co., Ltd..
Recruitment status was:  Recruiting
First Posted : August 18, 2009
Last Update Posted : August 24, 2009
Information provided by:
Dong-A ST Co., Ltd.

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitis Type 2 Drug: DA-1229 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2009
Estimated Primary Completion Date : February 2010
Estimated Study Completion Date : March 2010

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo

Experimental: 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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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) ]

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

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

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): NCT00961025

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

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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.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: KEUMJAE KO / Assistant Manager, Clinical Development Team 1
ClinicalTrials.gov Identifier: NCT00961025    
Other Study ID Numbers: DA1229_DM_I
First Posted: August 18, 2009    Key Record Dates
Last Update Posted: August 24, 2009
Last Verified: August 2009