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

August 20, 2009 updated by: Dong-A Pharmaceutical Co., Ltd.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kyung-Sang Yu, M.D., Ph.d., M.B.A.
  • Phone Number: +82-2-2072-1920
  • Email: ksyu@snuh.ac.kr

Study Locations

  • Korea, Republic of
    • Chongo-Gu, Yon-Gon Dong
      • Seoul, Chongo-Gu, Yon-Gon Dong, Korea, Republic of, 110-744
        • Recruiting
        • Clinical trials center, Seoul national university hospital
        • Contact:
          • Kyung-Sang Yu, M.D., Ph.D., M.B.A
          • Phone Number: +82-2-2072-1920
          • Email: 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Multiple blood and urine samples will be collected for 120 hours after dosing of DA-1229

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
up to 10 days (single dose study), 17 days (single dose study for food effect), 20 days (multiple dose study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Anticipated)

February 1, 2010

Study Completion (Anticipated)

March 1, 2010

Study Registration Dates

First Submitted

August 10, 2009

First Submitted That Met QC Criteria

August 17, 2009

First Posted (Estimate)

August 18, 2009

Study Record Updates

Last Update Posted (Estimate)

August 24, 2009

Last Update Submitted That Met QC Criteria

August 20, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • DA1229_DM_I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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