Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT05895812
Status:
COMPLETED
Last Update Posted:
2023-09-26
First Post:
2023-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function
Sponsor:
Shanghai Vinnerna Biosciences Co., Ltd.
Organization:
Study Overview
Official Title:
A Non-Random, Open-label, Parallel-group Study to Assess the Pharmacokinetics of JT001 in Subjects With Mild and Moderate Renal Impairment Compared to Subjects With Normal Renal Function
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the pharmacokinetics and safety of a single dose of JT001 in adult subjects with mild and moderate renal impairment compared to healthy mean-matched subjects.The results of this study will guide the clinical recommendation regarding whether or not a dose adjustment may be needed when treating patients with renal impairment.
Detailed Description:
This study will compare the pharmacokinetics of JT001 in patients with normal, mild or moderate renal impairment.There are 3 periods in the study including screening(D-28\~D-1 prior to investigation product administration) 、treatment and assessment (D1\~D4 domiciled in study center) and telephone follow-up(D7).
Twenty-four males and female volunteers between 18-65 years of age with BMI between 19- 28 kg/m2 will be divided into 3 groups of 8 subjects each based on renal function as defined (8 normal, 8 mild impairment, 8 moderate impairment).Participants in the renal impairment groups will be staged by their respective degree of renal function (mild or moderate) according to the estimated glomerular filtration rate (eGFR) determined at the screening visit. In order to exclude other factors that may affect the nature of PK, each renal impairment participant must be matched to a healthy control participant with respect to gender、age (±10 years) and body weight (±10kg).The subjects received a single dose of JT001 and collected blood and urine samples before and after administration for pharmacokinetic analysis.
After enrollment,subjects will be confined to the study unit during the entire 4 day study period.On day 1, after a fast of at least 10 hours, each patient will receive a single oral dose 0.3g of JT001. Blood and urine samples will be collected at times sufficient to adequately define the pharmacokinetics of JT001 active metabolite(116N-1) in the three study groups. Subjects will be monitored regarding adverse effects throughout study participation.
Twenty-four males and female volunteers between 18-65 years of age with BMI between 19- 28 kg/m2 will be divided into 3 groups of 8 subjects each based on renal function as defined (8 normal, 8 mild impairment, 8 moderate impairment).Participants in the renal impairment groups will be staged by their respective degree of renal function (mild or moderate) according to the estimated glomerular filtration rate (eGFR) determined at the screening visit. In order to exclude other factors that may affect the nature of PK, each renal impairment participant must be matched to a healthy control participant with respect to gender、age (±10 years) and body weight (±10kg).The subjects received a single dose of JT001 and collected blood and urine samples before and after administration for pharmacokinetic analysis.
After enrollment,subjects will be confined to the study unit during the entire 4 day study period.On day 1, after a fast of at least 10 hours, each patient will receive a single oral dose 0.3g of JT001. Blood and urine samples will be collected at times sufficient to adequately define the pharmacokinetics of JT001 active metabolite(116N-1) in the three study groups. Subjects will be monitored regarding adverse effects throughout study participation.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: