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

Sponsor

Dong-A Pharmaceutical Co., Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00961025

Collaborator

(none)

110

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Anticipated 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 1, 2009

Anticipated Primary Completion Date :

Feb 1, 2010

Anticipated Study Completion Date :

Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Drug: Placebo placebo
Experimental: DA-1229 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

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Drug: Placebo

placebo

Experimental: DA-1229

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Trials Center, Seoul National University Hospital	Seoul	Chongo-Gu, Yon-Gon Dong	Korea, Republic of	110-744

Sponsors and Collaborators

Dong-A Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00961025

Other Study ID Numbers:

DA1229_DM_I

First Posted:

Aug 18, 2009

Last Update Posted:

Aug 24, 2009

Last Verified:

Aug 1, 2009

Study Results

No Results Posted as of Aug 24, 2009