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Status unknownNCT00961025Updated Aug 24, 2009

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

A Phase 1 interventional study of DA-1229 and Placebo in Diabetes Mellitis Type 2, sponsored by Dong-A Pharmaceutical Co., Ltd.. Status unknown at 1 site in Korea, Republic of. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-08-24.

Sponsored by Dong-A Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Male
01

Study 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.

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Conditions studied

  • Diabetes Mellitis Type 2
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In context

Lead sponsor

Dong-A Pharmaceutical Co., Ltd. is the lead sponsor of 19 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
110 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    DA-1229

    DA-1229

    Drug: DA-1229

Interventions

  • DrugDA-1229

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

  • DrugPlacebo

    placebo

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What researchers measure

Primary outcomes

  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 outcomes

  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)

07

Study locations

1 of 1 sites recruiting
  • Clinical Trials Center, Seoul National University Hospital
    Seoul, Chongo-Gu, Yon-Gon Dong 110-744, Korea, Republic of
    • Kyung-Sang Yu, M.D., Ph.D., M.B.A · Contact · ksyu@snu.ac.kr · +82-2-2072-1920
    • Kyung-Sang Yu, M.D.,Ph.D.,M.B.A. · Principal investigator
    • In-Jin Jang, M.D.,Ph.D. · Sub investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 22943970 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00961025
Lead sponsor
Dong-A Pharmaceutical Co., Ltd.
First posted
Aug 18, 2009
Start date
May 2009
Primary completion
Feb 2010 (estimated)
Completion
Mar 2010 (estimated)
Last update
Aug 24, 2009

Study contacts

Kyung-Sang Yu, M.D., Ph.d., M.B.A.
Contact
ksyu@snuh.ac.kr
+82-2-2072-1920
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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