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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
24
JT001 single dose, 0.3g
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, China
Evaluate the impact on the Cmax of the main metabolite 116-N1 of JT001;
maximum observed plasma concentration
Time frame: From time zero up to 72 hours post-dose following oral administration of JT001
Evaluate the impact on the AUC0-t of the main metabolite 116-N1 of JT001;
area under the plasma concentration time curve from time zero to the last measurable concentration
Time frame: From time zero up to 72 hours post-dose following oral administration of JT001
Evaluate the impact on the AUC0-inf of the main metabolite 116-N1 of JT001;
area under the plasma concentration-time curve from time zero to infinity
Time frame: From time zero up to 72 hours post-dose following oral administration of JT001
Tmax of the main metabolite 116-N1 of JT001;
Evaluate the impact on the Tmax of the main metabolite 116-N1 of JT001;
Time frame: From time zero up to 72 hours post-dose following oral administration of JT001
t1/2 of the main metabolite 116-N1 of JT001;
Evaluate the impact on the t1/2 of the main metabolite 116-N1 of JT001;
Time frame: From time zero up to 72 hours post-dose following oral administration of JT001
CL/F of the main metabolite 116-N1 of JT001;
Evaluate the impact on the CL/F of the main metabolite 116-N1 of JT001;
Time frame: From time zero up to 72 hours post-dose following oral administration of JT001
Vz/F of the main metabolite 116-N1 of JT001;
Evaluate the impact on the Vz/F of the main metabolite 116-N1 of JT001;
Time frame: From time zero up to 72 hours post-dose following oral administration of JT001
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Ae of the main metabolite 116-N1 of JT001;
Evaluate the impact on the Ae of the main metabolite 116-N1 of JT001;
Time frame: From time zero up to 72 hours post-dose following oral administration of JT001
CLr of the main metabolite 116-N1 of JT001;
Evaluate the impact on the CLr of the main metabolite 116-N1 of JT001;
Time frame: From time zero up to 72 hours post-dose following oral administration of JT001
Ae% of the main metabolite 116-N1 of JT001;
Evaluate the impact on the Ae% of the main metabolite 116-N1 of JT001;
Time frame: From time zero up to 72 hours post-dose following oral administration of JT001
The incidence and severity of adverse events (TEAEs) of serious adverse events (SAE) occurred during the treatment were observed.
The incidence and severity of adverse events (TEAEs) of serious adverse events (SAE) occurred during the treatment were observed.
Time frame: From Day 1(first dose) to Day7
The incidence and severity of adverse events (TEAEs) of clinical symptoms occurred during the treatment were observed.
The incidence and severity of adverse events (TEAEs) of clinical symptoms occurred during the treatment were observed.
Time frame: From Day 1(first dose) to Day7
The incidence and severity of adverse events (TEAEs) of vital signs occurred during the treatment were observed.
The incidence and severity of adverse events (TEAEs) of vital signs occurred during the treatment were observed.
Time frame: From Day 1(first dose) to Day7
The incidence and severity of adverse events (TEAEs) of physical examination occurred during the treatment were observed.
The incidence and severity of adverse events (TEAEs) of physical examination occurred during the treatment were observed.
Time frame: From Day 1(first dose) to Day7
The incidence and severity of adverse events (TEAEs) of laboratory examination occurred during the treatment were observed.
The incidence and severity of adverse events (TEAEs) of laboratory examination occurred during the treatment were observed.
Time frame: From Day 1(first dose) to Day7
The incidence and severity of adverse events (TEAEs) of abnormal electrocardiogram (ECG) occurred during the treatment were observed.
The incidence and severity of adverse events (TEAEs) of abnormal electrocardiogram (ECG) occurred during the treatment were observed.
Time frame: From Day 1(first dose) to Day7