A Study to Evaluate the Pharmacokinetics and Safety of YHD1119 in Subjects With Renal Impairment and Healthy Subjects
1 other identifier
interventional
16
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2021
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 24, 2021
CompletedFirst Submitted
Initial submission to the registry
July 27, 2021
CompletedFirst Posted
Study publicly available on registry
August 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2022
CompletedJune 30, 2022
June 1, 2022
10 months
July 27, 2021
June 28, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
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
Study Arms (2)
YHD1119 75mg, 150mg NF
EXPERIMENTALCLcr (mL/min/1.73m2) \>= 60 Period 1 : YHD1119 75 mg Period 2 : YHD1119 150 mg NF
YHD1119 75mg
EXPERIMENTAL60 \> CLcr (mL/min/1.73m2) \>= 30 Period 1 : YHD1119 75 mg Period 2 : NA
Interventions
Eligibility Criteria
You may qualify if:
- \~75 years old, healthy volunteers and renal impairments
- eGFR \>= 60mL/min/1.73m2
- mL/min/1.73m2 \> eGFR \>= 30mL/min/1.73m2
- written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHA Bundang Medical Center, CHA University
Gyeonggi-do, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
Related Publications (1)
Park M, Choi S, Han S, Shin W, Kim A, Han S, Kim B, Lim Y, Yoo H. Pharmacokinetic properties of a new sustained-release pregabalin tablet in subjects with reduced renal function. Transl Clin Pharmacol. 2023 Dec;31(4):226-237. doi: 10.12793/tcp.2023.31.e20. Epub 2023 Dec 20.
PMID: 38197000DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
SeungHoon Han
The Catholic University of Korea
- PRINCIPAL INVESTIGATOR
Hyounggyoon Yoo
CHA University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2021
First Posted
August 19, 2021
Study Start
July 24, 2021
Primary Completion
May 10, 2022
Study Completion
May 10, 2022
Last Updated
June 30, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share