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

August 10, 2009
August 20, 2009
May 2009
February 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00961025 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Study to Characterize the Pharmacokinetics/Pharmacodynamics and Effect of Food of DA-1229 in Healthy Male Subjects
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitis Type 2
  • 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

  • Drug: Placebo
    placebo
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: DA-1229
    DA-1229
    Intervention: Drug: DA-1229
Kim TE, Lim KS, Park MK, Yoon SH, Cho JY, Shin SG, Jang IJ, Yu KS. Evaluation of the pharmacokinetics, food effect, pharmacodynamics, and tolerability of DA-1229, a dipeptidyl peptidase IV inhibitor, in healthy volunteers: first-in-human study. Clin Ther. 2012 Sep;34(9):1986-98. doi: 10.1016/j.clinthera.2012.08.006. Epub 2012 Sep 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
110
March 2010
February 2010   (final data collection date for primary outcome measure)

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
Male
20 Years to 45 Years
Yes
Contact: Kyung-Sang Yu, M.D., Ph.d., M.B.A. +82-2-2072-1920 ksyu@snuh.ac.kr
Korea, Republic of
 
NCT00961025
DA1229_DM_I
Not Provided
KEUMJAE KO / Assistant Manager, Clinical Development Team 1
Dong-A Pharmaceutical Co., Ltd.
Not Provided
Not Provided
Dong-A Pharmaceutical Co., Ltd.
August 2009

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