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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer; Renal Impairments
• Intervention / Treatment: Drug: YHD1119 75mg

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of
    • CHA Bundang Medical Center, CHA University
  • Seoul, Korea, Republic of
    • The Catholic University of Korea, Seoul St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: YHD1119 75mg, 150mg NF; CLcr (mL/min/1.73m2) >= 60 Period 1 : YHD1119 75 mg Period 2 : YHD1119 150 mg NF	Drug: YHD1119 75mg; A single oral dose; Other Names: YHD1119 150mg NF
Experimental: YHD1119 75mg; 60 > CLcr (mL/min/1.73m2) >= 30 Period 1 : YHD1119 75 mg Period 2 : NA	Drug: YHD1119 75mg; A single oral dose; Other Names: YHD1119 150mg NF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax	0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour
AUClast	0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour

Secondary Outcome Measures

Outcome Measure	Time Frame
AUCinf	0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour
Tmax	0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour
t1/2	0,1,2,3,4,5,6,8,10,12,14,24,48,72hour
CL/F	0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour
V/F	0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour

Collaborators and Investigators

• Sponsor: Yuhan Corporation
• Investigators: Principal Investigator: SeungHoon Han, The Catholic University of Korea; Principal Investigator: Hyounggyoon Yoo, CHA University

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2021
• Primary Completion (Actual): May 10, 2022
• Study Completion (Actual): May 10, 2022

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: YHD1119-107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No