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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00961025

Enrollment

110

Registered

2009-08-18

Start date

2009-05-31

Completion date

2010-03-31

Last updated

2009-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitis Type 2

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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame
To characterize the pharmacokinetic/pharmacodynamic of DA-1229 in healthy male subjects	Multiple blood and urine samples will be collected for 120 hours after dosing of DA-1229

Secondary

Measure	Time frame
To evaluate the safety and tolerance of DA-1229	up to 10 days (single dose study), 17 days (single dose study for food effect), 20 days (multiple dose study)

Countries

South Korea

Contacts

Primary ContactKyung-Sang Yu, M.D., Ph.d., M.B.A.

ksyu@snuh.ac.kr+82-2-2072-1920

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026