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A Study to Evaluate the Pharmacokinetics and Safety of YHD1119 in Subjects With Renal Impairment and Healthy Subjects

Primary Purpose

Healthy Volunteer, Renal Impairments

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

YHD1119 75mg

About this trial

This is an interventional treatment trial for Healthy Volunteer

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

19~75 years old, healthy volunteers and renal impairments
eGFR >= 60mL/min/1.73m2
60 mL/min/1.73m2 > eGFR >= 30mL/min/1.73m2
written informed consent

Exclusion Criteria:

AST or ALT > 1.5 * Upper normal range
Total bilirubin > 1.5 * Upper normal range
Blood CPK > 1.5 * Upper normal range
Total Cholesterol >1.5 * Upper normal range
Woman who is pregnant or lactating
Patients who are difficult to participate in cinical trials judged by Investigators
have participated in other clinical trials within 180 days before IP intake

Sites / Locations

CHA Bundang Medical Center, CHA University
The Catholic University of Korea, Seoul St. Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

YHD1119 75mg, 150mg NF

YHD1119 75mg

Arm Description

CLcr (mL/min/1.73m2) >= 60 Period 1 : YHD1119 75 mg Period 2 : YHD1119 150 mg NF

60 > CLcr (mL/min/1.73m2) >= 30 Period 1 : YHD1119 75 mg Period 2 : NA

Outcomes

Primary Outcome Measures

Cmax

AUClast

Secondary Outcome Measures

AUCinf

Tmax

t1/2

CL/F

V/F

Full Information

NCT ID

NCT05012436

First Posted

July 27, 2021

Last Updated

June 28, 2022

Sponsor

Yuhan Corporation

1. Study Identification

Unique Protocol Identification Number

NCT05012436

Brief Title

A Study to Evaluate the Pharmacokinetics and Safety of YHD1119 in Subjects With Renal Impairment and Healthy Subjects

Official Title

A Study to Evaluate the Pharmacokinetics and Safety Following a Single Oral Dose of YHD1119 in Subjects With Renal Impairment and Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

July 24, 2021 (Actual)

Primary Completion Date

May 10, 2022 (Actual)

Study Completion Date

May 10, 2022 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this trial is to compare the pharmacokinetic characteristics and safety of YHD1119(Pregabalin SR 75mg) and YHD1119(Pregabalin SR 150mg) in subjects with renal impairment and healthy subjects. YHD1119 is sustained-release (SR) formulation which is made by Yuhan Corporation. Primary endpoints are Cmax and AUClast and secondary endpoints are AUCinf,Tmax, t1/2, CL/F and V/F.

6. Conditions and Keywords

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

Healthy Volunteer, Renal Impairments

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

YHD1119 75mg, 150mg NF

Arm Type

Experimental

Arm Description

CLcr (mL/min/1.73m2) >= 60 Period 1 : YHD1119 75 mg Period 2 : YHD1119 150 mg NF

Arm Title

YHD1119 75mg

Arm Type

Experimental

Arm Description

60 > CLcr (mL/min/1.73m2) >= 30 Period 1 : YHD1119 75 mg Period 2 : NA

Intervention Type

Drug

Intervention Name(s)

YHD1119 75mg

Other Intervention Name(s)

YHD1119 150mg NF

Intervention Description

A single oral dose

Primary Outcome Measure Information:

Title

Cmax

Time Frame

0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour

Title

AUClast

Time Frame

0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour

Secondary Outcome Measure Information:

Title

AUCinf

Time Frame

0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour

Title

Tmax

Time Frame

0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour

Title

t1/2

Time Frame

0,1,2,3,4,5,6,8,10,12,14,24,48,72hour

Title

CL/F

Time Frame

0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour

Title

V/F

Time Frame

0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 19~75 years old, healthy volunteers and renal impairments eGFR >= 60mL/min/1.73m2 60 mL/min/1.73m2 > eGFR >= 30mL/min/1.73m2 written informed consent Exclusion Criteria: AST or ALT > 1.5 * Upper normal range Total bilirubin > 1.5 * Upper normal range Blood CPK > 1.5 * Upper normal range Total Cholesterol >1.5 * Upper normal range Woman who is pregnant or lactating Patients who are difficult to participate in cinical trials judged by Investigators have participated in other clinical trials within 180 days before IP intake

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

SeungHoon Han

Organizational Affiliation

The Catholic University of Korea

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hyounggyoon Yoo

Organizational Affiliation

CHA University

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHA Bundang Medical Center, CHA University

City

Gyeonggi-do

Country

Korea, Republic of

Facility Name

The Catholic University of Korea, Seoul St. Mary's Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Study to Evaluate the Pharmacokinetics and Safety of YHD1119 in Subjects With Renal Impairment and Healthy Subjects

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