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Study to Assess PK/PD Character, Safety/Tolerability of CKD-519 New Formulation in Healthy Male Subject.

Primary Purpose

Dyslipidemia

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

CKD-519 50mg 2Tabs.

CKD-519 100mg 1Tab.

CKD-519 100mg 1Cap.

About this trial

This is an interventional treatment trial for Dyslipidemia

Eligibility Criteria

20 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Between 20 aged and 45 aged in healthy male adult
Body weight ≥ 50kg and in the range of calculated BMI(Body Mass Index) 18~29kg/m2
Subject who sign on an informed consent form willingly
Necessarily he agrees that use double contraceptions and do not sperm donation until two months during clinical trials and after the final dosage of investigational products

Exclusion Criteria:

Clinically significant disease with cardiovascular, respiratory, hepatobiliary, nephrological, hematological, gastrointestinal, endocrine, immune, integumentary, neurologic, psychiatric system
Have a acute disease within 28 days before the beginning of study treatment
Have a disease history that can effect drug absorption, distribution, metabolism, excretion
Have a clinically significant chronic disease
Systolic blood pressure <100mmHg or >140mmHg, diastolic blood pressure<60mmHg or >90mmHg
Positive for serology test (HBsAg, anti-HCV Ab, anti-HIV Ab, VDRL(Venereal Disease Research Laboratories))
Subject treated ethical drug within 14 days before the beginning of study treatment
Subject treated over-the-counter or herbal medicine within 7 days before the beginning of study treatment
Have a clinically significant allergic disease (except for mild allergic rhinitis, allergic dermatitis with no drugs)
Cannot take standard Meal
Whole blood donation within 60 days prior to the first dosing or component blood donation within 20 days prior to the first dosing
Blood transfusion within 30 days
Taking drugs have received any other investigational drug within 90 days prior to the first dosing
Continuously taking caffeine(>5 cups/day), drinking alcohol(>30g/day), smoking excessive cigarettes(>10cigarettes/day)
Impossible on who participants in clinical trial by investigator's decision including laboratory test result or another reasone(for example, noncompliance, a disobliging manner)
Subject treated metabolizing enzyme inducers or inhibitors including barbiturates within 30 days

Sites / Locations

Korea university medical center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Group 5

Group 6

Arm Description

A-B-C (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)

B-C-A (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)

C-A-B (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)

A-C-B (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)

B-A-C (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)

C-B-A (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)

Outcomes

Primary Outcome Measures

Cmax of CKD-519

Tmax of CKD-519

AUClast of CKD-519

AUC0-∞ of CKD-519

t1/2 of CKD-519

CL/F of CKD-519

Vd/F of CKD-519

Emax of CKD-519 CETP(Cholesteryl ester transfer protein) Activity

Tmax of CKD-519 CETP Activity

AUEC of CKD-519 CETP Activity

EC50(half maximal effective concentration ) of CKD-519 CETP Activity

Secondary Outcome Measures

Full Information

NCT ID

NCT02623868

First Posted

October 23, 2015

Last Updated

January 17, 2016

Sponsor

Chong Kun Dang Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT02623868

Brief Title

Study to Assess PK/PD Character, Safety/Tolerability of CKD-519 New Formulation in Healthy Male Subject.

Official Title

Clinical Trial to Assess the Pharmacokinetic/Pharmacodynamic Characteristics and Safety/Tolerability of CKD-519 New Formulation in Healthy Male Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

October 2015 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chong Kun Dang Pharmaceutical

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Study to assess the pharmacokinetic/pharmacodynamic characteristics and safety/tolerability to CKD-519 new formulation in healthy male subjects.

Detailed Description

Open-label, Randomized, 3-period, 6-sequence, crossover study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyslipidemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

A-B-C (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)

Arm Title

Group 2

Arm Type

Experimental

Arm Description

B-C-A (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)

Arm Title

Group 3

Arm Type

Experimental

Arm Description

C-A-B (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)

Arm Title

Group 4

Arm Type

Experimental

Arm Description

A-C-B (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)

Arm Title

Group 5

Arm Type

Experimental

Arm Description

B-A-C (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)

Arm Title

Group 6

Arm Type

Experimental

Arm Description

C-B-A (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)

Intervention Type

Drug

Intervention Name(s)

CKD-519 50mg 2Tabs.

Other Intervention Name(s)

Drug A

Intervention Description

after taking Standard meal, CKD-519 50mg 2Tabs. administration.

Intervention Type

Drug

Intervention Name(s)

CKD-519 100mg 1Tab.

Other Intervention Name(s)

Drug B

Intervention Description

after taking Standard meal, CKD-519 100mg 1Tab. administration.

Intervention Type

Drug

Intervention Name(s)

CKD-519 100mg 1Cap.

Other Intervention Name(s)

Drug C

Intervention Description

after taking Standard meal, CKD-519 100mg 1Cap. administration.

Primary Outcome Measure Information:

Title

Cmax of CKD-519

Time Frame