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Phase 1 to Evaluate the Safety and Pharmacokinetic Characteristics of Fixed-dose Combination of YYC506

Primary Purpose

Dyslipidemias

Status

Unknown status

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

YYC506-T and YYC506-A (phase 1)

YYC506 (phase 1)

YYC506-T and YYC506-A (phase 2)

YYC506 (phase 2)

About this trial

This is an interventional treatment trial for Dyslipidemias

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Over 19 ages healthy men
Over 50.0kg, 18.0kg/m2 ≤ BMI ≤ 30.0kg/m2
Men who don't have congenital disease and other cronic disease need to be cared. etc.

Exclusion Criteria:

Men who have congenital liver disease (AST, ALT, CK ≥ 2X ULN)
Men who have drunken or eatten something including caffeine within 24 hours before. etc.

Sites / Locations

Chungbuk National Unviersity Hosipital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

A Group

B Group

Arm Description

Two-way Crossover

Outcomes

Primary Outcome Measures

Pharmacokinetic parameters: Cmax

Cmax

Pharmacokinetic parameters: AUC

YYC506-T, YYC506-A, YYC506 AUC

Secondary Outcome Measures

Full Information

NCT ID

NCT04874129

First Posted

April 20, 2021

Last Updated

May 4, 2021

Sponsor

Yooyoung Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04874129

Brief Title

Phase 1 to Evaluate the Safety and Pharmacokinetic Characteristics of Fixed-dose Combination of YYC506

Official Title

Phase 1 to Evaluate the Safety and Pharmacokinetic Characteristics of Fixed-dose Combination of YYC506

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

January 7, 2021 (Actual)

Primary Completion Date

May 31, 2021 (Anticipated)

Study Completion Date

July 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yooyoung Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To evaluate the safety and pharmacokinetics characteristics between YYC506 and concomitant administration of YYC506-T and YYC506-A

Detailed Description

Phase 1 to evaluate the safety and pharmacokinetics characteristics between YYC506 and concomitant administration of YYC506-T and YYC506-A. Which is designed as ramdomized, oral, single dose, two-way crossover.

6. Conditions and Keywords

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

Dyslipidemias

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Model Description

ramdomized, open-label, single-dose, two-way crossover study

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

A Group

Arm Type

Other

Arm Description

Two-way Crossover

Arm Title

B Group

Arm Type

Other

Arm Description

Two-way Crossover

Intervention Type

Drug

Intervention Name(s)

YYC506-T and YYC506-A (phase 1)

Other Intervention Name(s)

Comparator

Intervention Description

Comparator

Intervention Type

Drug

Intervention Name(s)

YYC506 (phase 1)

Other Intervention Name(s)

Test

Intervention Description

Test

Intervention Type

Drug

Intervention Name(s)

YYC506-T and YYC506-A (phase 2)

Other Intervention Name(s)

Comparator

Intervention Description

Comparator

Intervention Type

Drug

Intervention Name(s)

YYC506 (phase 2)

Other Intervention Name(s)

Test

Intervention Description

Test

Primary Outcome Measure Information:

Title

Pharmacokinetic parameters: Cmax

Description

Cmax

Time Frame

Until 48 hours

Title

Pharmacokinetic parameters: AUC

Description

YYC506-T, YYC506-A, YYC506 AUC

Time Frame

Until 48 hours

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Over 19 ages healthy men Over 50.0kg, 18.0kg/m2 ≤ BMI ≤ 30.0kg/m2 Men who don't have congenital disease and other cronic disease need to be cared. etc. Exclusion Criteria: Men who have congenital liver disease (AST, ALT, CK ≥ 2X ULN) Men who have drunken or eatten something including caffeine within 24 hours before. etc.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Min Kyu Park, PhD

Organizational Affiliation

Chungbuk National University Hosipital.

Official's Role

Study Chair

Facility Information:

Facility Name

Chungbuk National Unviersity Hosipital

City

Cheongju-si

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Phase 1 to Evaluate the Safety and Pharmacokinetic Characteristics of Fixed-dose Combination of YYC506

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