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A Study to Investigate Drug Interaction Between D326, D337, and D013 in Healthy Male Subjects

Primary Purpose

Dyslipidemias, Hypertension

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

D013, D326 and D337

D013

D326 and D337

About this trial

This is an interventional treatment trial for Dyslipidemias focused on measuring Dyslipidemia, Hypertension, CKD-386, Drug-Drug Interaction

Eligibility Criteria

20 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Healthy volunteers aged between ≥ 20 and ≤ 45 years old
Weight ≥ 50kg, with calculated body mass index(BMI) of ≥ 18 and ≤ 29.9kg/m²
Subjects who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods for up to 28 days after the date of administration of the clinical trial drug and agree not to provide sperm
Subject who are informed of the investigational nature of this study, voluntarily agree to participate in this study

Exclusion Criteria:

History or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic or psychiatric disorder
With symptoms indicating acute illness within 28 days prior to the first Investigational Product administration
Any medical history that may affect drug absorption, distribution, metabolism and excretion
Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
Any clinically significant active chronic disease

Sites / Locations

Korea University Anam Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Part A, Sequence1

Part A, Sequence 2

Part B, Sequence 1

Part B, Sequence 2

Arm Description

Period 1: Treatment of D013, D326 and D337 on Day1~Day7 Period 2: Treatment of D013 on Day22~Day28

Period 1: Treatment of D013 on Day1~Day7 Period 2: Treatment of D013, D326 and D337 on Day22~Day28

Period 1: Treatment of D013, D326 and D337 on Day1~Day7 Period 2: Treatment of D326 and D337 on Day22~Day28

Period 1: Treatment of D326 and D337 on Day1~Day7 Period 2: Treatment of D013, D326 and D337 on Day22~Day28

Outcomes

Primary Outcome Measures

AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state)

Part A: Pharmacokinetic parameter of D013 after multiple dosing Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing

Cmax,ss(Maximum plasma concentration of the drug at steady state)

Part A: Pharmacokinetic parameter of D013 after multiple dosing Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing

Secondary Outcome Measures

Cmin,ss(Minimum concentration of the drug in plasma at steady state)

Part A: Pharmacokinetic parameter of D013 after multiple dosing Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing

Tmax,ss(Time to maximum plasma concentration at steady state)

Part A: Pharmacokinetic parameter of D013 after multiple dosing Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing

t1/2(Terminal elimination half-life)

Part A: Pharmacokinetic parameter of D013 after multiple dosing Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing

CLss/F(Apparent total body clearance of the drug from plasma at steady state)

Part A: Pharmacokinetic parameter of D013 after multiple dosing Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing

Vd,ss/F(Apparent volume of distribution at steady state)

Part A: Pharmacokinetic parameter of D013 after multiple dosing Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing

PTF(Peak-to-trough fluctuation)

Part A: Pharmacokinetic parameter of D013 after multiple dosing Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing

Full Information

NCT ID

NCT03609606

First Posted

July 25, 2018

Last Updated

October 4, 2018

Sponsor

Chong Kun Dang Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT03609606

Brief Title

A Study to Investigate Drug Interaction Between D326, D337, and D013 in Healthy Male Subjects

Official Title

An Open-label, Randomized, Multiple-dose Crossover Study to Investigate Drug Interaction Between D326, D337, and D013 in Healthy Male Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

August 9, 2018 (Actual)

Primary Completion Date

September 14, 2018 (Actual)

Study Completion Date

September 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chong Kun Dang Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

A study to investigate drug interaction between D326, D337, and D013 in healthy male subjects

Detailed Description

An open-label, randomized, multiple-dose crossover study to investigate drug interaction between D326, D337, and D013 in healthy male subjects

6. Conditions and Keywords

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

Dyslipidemias, Hypertension

Keywords

Dyslipidemia, Hypertension, CKD-386, Drug-Drug Interaction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

69 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part A, Sequence1

Arm Type

Experimental

Arm Description

Period 1: Treatment of D013, D326 and D337 on Day1~Day7 Period 2: Treatment of D013 on Day22~Day28

Arm Title

Part A, Sequence 2

Arm Type

Experimental

Arm Description

Period 1: Treatment of D013 on Day1~Day7 Period 2: Treatment of D013, D326 and D337 on Day22~Day28

Arm Title

Part B, Sequence 1

Arm Type

Experimental

Arm Description

Period 1: Treatment of D013, D326 and D337 on Day1~Day7 Period 2: Treatment of D326 and D337 on Day22~Day28

Arm Title

Part B, Sequence 2

Arm Type

Experimental

Arm Description

Period 1: Treatment of D326 and D337 on Day1~Day7 Period 2: Treatment of D013, D326 and D337 on Day22~Day28

Intervention Type

Drug

Intervention Name(s)

D013, D326 and D337

Other Intervention Name(s)

CKD-386 Test

Intervention Description

Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days

Intervention Type

Drug

Intervention Name(s)

D013

Other Intervention Name(s)

CKD-386 Reference1

Intervention Description

Daily oral administration of 1 tablet under fasting conditions for 7 days

Intervention Type

Drug

Intervention Name(s)

D326 and D337

Other Intervention Name(s)

CKD-386 Reference2

Intervention Description

Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days

Primary Outcome Measure Information:

Title

AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state)

Description

Part A: Pharmacokinetic parameter of D013 after multiple dosing Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing

Time Frame

0(predose)~24 hours at Day7 and Day28

Title

Cmax,ss(Maximum plasma concentration of the drug at steady state)

Description

Part A: Pharmacokinetic parameter of D013 after multiple dosing Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing

Time Frame

0(predose)~24 hours at Day7 and Day28

Secondary Outcome Measure Information:

Title

Cmin,ss(Minimum concentration of the drug in plasma at steady state)

Description

Part A: Pharmacokinetic parameter of D013 after multiple dosing Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing

Time Frame

0(predose)~24 hours at Day7 and Day28

Title

Tmax,ss(Time to maximum plasma concentration at steady state)

Description

Part A: Pharmacokinetic parameter of D013 after multiple dosing Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing

Time Frame

0(predose)~24 hours at Day7 and Day28

Title

t1/2(Terminal elimination half-life)

Description

Part A: Pharmacokinetic parameter of D013 after multiple dosing Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing

Time Frame

0(predose)~24 hours at Day7 and Day28

Title

CLss/F(Apparent total body clearance of the drug from plasma at steady state)

Description

Part A: Pharmacokinetic parameter of D013 after multiple dosing Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing

Time Frame

0(predose)~24 hours at Day7 and Day28

Title

Vd,ss/F(Apparent volume of distribution at steady state)

Description

Part A: Pharmacokinetic parameter of D013 after multiple dosing Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing

Time Frame

0(predose)~24 hours at Day7 and Day28

Title

PTF(Peak-to-trough fluctuation)

Description

Part A: Pharmacokinetic parameter of D013 after multiple dosing Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing

Time Frame

0(predose)~24 hours at Day7 and Day28

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy volunteers aged between ≥ 20 and ≤ 45 years old Weight ≥ 50kg, with calculated body mass index(BMI) of ≥ 18 and ≤ 29.9kg/m² Subjects who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods for up to 28 days after the date of administration of the clinical trial drug and agree not to provide sperm Subject who are informed of the investigational nature of this study, voluntarily agree to participate in this study Exclusion Criteria: History or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic or psychiatric disorder With symptoms indicating acute illness within 28 days prior to the first Investigational Product administration Any medical history that may affect drug absorption, distribution, metabolism and excretion Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder Any clinically significant active chronic disease

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ji-Young Park, M.D., Ph.D

Organizational Affiliation

Department of Pharmacology, College of Medicine/ Department of Clinical Pharmacology&Toxicology, Anam Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Korea University Anam Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

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A Study to Investigate Drug Interaction Between D326, D337, and D013 in Healthy Male Subjects

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