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A Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between YHR1705 and YHR1706

Primary Purpose

Dyslipidemia, Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
YHR1705
YHR1706
YHR1705+YHR1706
Sponsored by
Yuhan Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia

Eligibility Criteria

19 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2
  • Who has not suffered from clinically significant disease
  • Provision of signed written informed consent

Exclusion Criteria:

  • History of and clinically significant disease
  • A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
  • Administration of other investigational products within 3 months prior to the first dosing
  • Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs

Sites / Locations

  • Chonbuk National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

5

6

Arm Description

5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 3.

5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 3.

5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1706 QD for 6 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 3.

5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1706 QD for 6 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 3. There will be a washout of at least 10 days between the last dose in one period and the first dose in the subsequent period.

5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 3.

5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 3.

Outcomes

Primary Outcome Measures

YHR1705, YHR1706 AUCtau
AUCtau
YHR1705, YHR1706 Css, max
Css,max

Secondary Outcome Measures

Full Information

First Posted
July 25, 2017
Last Updated
October 30, 2017
Sponsor
Yuhan Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03235362
Brief Title
A Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between YHR1705 and YHR1706
Official Title
A Phase 1, Randomized, Open-label, Multiple-dose, 3-treatment, 6-sequence, 3-period Crossover Clinical Trial to Investigate the Safety and Pharmacokinetic Drug Interaction Between YHR1705 and YHR1706 in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 7, 2017 (Actual)
Primary Completion Date
September 19, 2017 (Actual)
Study Completion Date
September 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a phase 1, open label, multiple-dose, crossover clinical trial to investigate the pharmacokinetic drug interaction between YHR1705 and YHR1706 in healty male volunteers
Detailed Description
This is an open-label, randomized, 6-sequence, 3-period crossover study. Subjects will receive multiple oral doses of YHR1705, YHR1706 or YHR1705 + YHR1706 QD for 5 consecutive days. There will be a washout of at least 10 days between the last dose in one period and the first dose in the subsequent period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia, Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 3.
Arm Title
2
Arm Type
Experimental
Arm Description
5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 3.
Arm Title
3
Arm Type
Experimental
Arm Description
5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1706 QD for 6 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 3.
Arm Title
4
Arm Type
Experimental
Arm Description
5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1706 QD for 6 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 3. There will be a washout of at least 10 days between the last dose in one period and the first dose in the subsequent period.
Arm Title
5
Arm Type
Experimental
Arm Description
5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 3.
Arm Title
6
Arm Type
Experimental
Arm Description
5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 3.
Intervention Type
Drug
Intervention Name(s)
YHR1705
Intervention Description
Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days in each period.
Intervention Type
Drug
Intervention Name(s)
YHR1706
Intervention Description
Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days in each period.
Intervention Type
Drug
Intervention Name(s)
YHR1705+YHR1706
Intervention Description
Subjects will receive multiple oral doses of YHR1705 + YHR1706 QD for 5 consecutive days in each period.
Primary Outcome Measure Information:
Title
YHR1705, YHR1706 AUCtau
Description
AUCtau
Time Frame
0 - 24hours
Title
YHR1705, YHR1706 Css, max
Description
Css,max
Time Frame
0 - 24hours

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Healthy male with body mass index (BMI) between 18.5kg/m2 and 30kg/m2
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2 Who has not suffered from clinically significant disease Provision of signed written informed consent Exclusion Criteria: History of and clinically significant disease A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs Administration of other investigational products within 3 months prior to the first dosing Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mingul Kim, MD
Organizational Affiliation
Chonbuk National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonbuk National University Hospital
City
Jeonju
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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A Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between YHR1705 and YHR1706

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