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

Diabetes Mellitis Type 2 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00961025
• Other study ID #: DA1229_DM_I
• Status: Recruiting
• Phase: Phase 1
• First received: August 10, 2009
• Last updated: August 20, 2009
• Start date: May 2009
• Est. completion date: March 2010

Study information

• Verified date: August 2009
• Source: Dong-A ST Co., Ltd.
• Contact: Kyung-Sang Yu, M.D., Ph.d., M.B.A.
• Phone: +82-2-2072-1920
• Email: ksyu[@]snuh.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: March 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitis Type 2

Intervention

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
• Placebo
placebo

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trials Center, Seoul National University Hospital	Seoul	Chongo-Gu, Yon-Gon Dong

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	Yes