Evaluate the pharmacokinetic differences of the main metabolite 116-N1 of JT001 in subjects with mild and moderate liver function impairment and those with normal liver function, providing a basis for formulating clinical medication plans for patients with liver function impairment;
This study adopts a non randomized, open, parallel controlled, single dose experimental design and is divided into three experimental groups: mild liver function impairment group (Group A), moderate liver function impairment group (Group B), and normal liver function subject group (Group C). Subjects in each experimental group took 0.3g of JT001 orally on an empty stomach and collected blood samples before and after administration for pharmacokinetic analysis. After both groups A and B were enrolled, Group C subjects will be enrolled subsequently and should be matched with subjects with liver function impairment (Group A and Group B) as following: The average body weight of Group C is within ± 10 kg of the average body weight of the group of subjects with liver function impairment (Groups A and B). The average age of Group C is within ± 10 years of the average age of the group of subjects with liver function impairment (Groups A and B). The number of subjects of each gender in Group C is similar to that in the liver function impairment group (A and B groups) (± 1 subject/gender). The study is divided into three stages: screening period, baseline period, and experimental period.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
24
JT001 single dose, 0.3g
The First Hospital of Jilin University Ethics Committee
Changchun, Jilin, China
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
The AUC0-t of the main metabolite 116-N1 of JT001;
area under the 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
The AUC0-inf of the main metabolite 116-N1 of JT001;
area under 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;
Time to maximum observed concentration 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;
Terminal phase half-life 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;
The clearance 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;
The apparent volume of distribution 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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The severity of SAE
The severity of SAE
Time frame: From Day 1(first dose) to Day7
The Number of participants with SAE
The Number of participants with SAE
Time frame: From Day 1(first dose) to Day7
The severity ofclinical symptoms abnormalities(e.g.,Dizziness, headache, nausea, abdominal pain, fatigue, drowsiness)
The severity ofclinical symptoms abnormalities(e.g.,Dizziness, headache, nausea, abdominal pain, fatigue, drowsiness)
Time frame: From Day 1(first dose) to Day7
The Number of participantswith abnormal clinical symptoms(e.g.,Dizziness, headache, nausea, abdominal pain, fatigue, drowsiness)
The Number of participantswith abnormal clinical symptoms(e.g.,Dizziness, headache, nausea, abdominal pain, fatigue, drowsiness)
Time frame: From Day 1(first dose) to Day7
The severity of vital signs abnormalities
The severity of Pulse abnormalities
Time frame: From Day 1(first dose) to Day7
The Number of participantswith abnormal vital signs
The Number of participantswith abnormal Pulse
Time frame: From Day 1(first dose) to Day7
The severity of vital signs abnormalities
The severity of blood pressure abnormalities
Time frame: From Day 1(first dose) to Day7
The Number of participantswith abnormal vital signs
The Number of participantswith abnormal blood pressure
Time frame: From Day 1(first dose) to Day7
The severity of vital signs abnormalities
The severity of respiration abnormalities
Time frame: From Day 1(first dose) to Day7
The Number of participantswith abnormal vital signs
The Number of participantswith abnormal respiration
Time frame: From Day 1(first dose) to Day7
The severity of vital signs abnormalities
The severity of body temperature abnormalities
Time frame: From Day 1(first dose) to Day7
The Number of participantswith abnormal vital signs
The Number of participantswith abnormal body temperature
Time frame: From Day 1(first dose) to Day7
The severity of abnormal physical examinations findings
The severity of abnormal physical examinations findings
Time frame: From Day 1(first dose) to Day7
The Number of participantswith abnormal physical examinations findings
The Number of participantswith abnormal physical examinations findings
Time frame: From Day 1(first dose) to Day7
The severity of abnormal laboratory tests results
The severity of abnormal laboratory tests results
Time frame: From Day 1(first dose) to Day7
The Number of participantswith abnormal laboratory tests results
The Number of participantswith abnormal laboratory tests results
Time frame: From Day 1(first dose) to Day7
The severity of electrocardiogram (ECG) abnormalities
The severity of Heart rate abnormalities
Time frame: From Day 1(first dose) to Day7
The Number of participants with electrocardiogram (ECG) abnormalities
The Number of participants with Heart rate abnormalities
Time frame: From Day 1(first dose) to Day7
The severity of electrocardiogram (ECG) abnormalities
The severity of PR interval abnormalities
Time frame: From Day 1(first dose) to Day7
The Number of participants with electrocardiogram (ECG) abnormalities
The Number of participants with PR interval abnormalities
Time frame: From Day 1(first dose) to Day7
The severity of electrocardiogram (ECG) abnormalities
The severity of QRS interval abnormalities
Time frame: From Day 1(first dose) to Day7
The Number of participants with electrocardiogram (ECG) abnormalities
The Number of participants with QRS interval abnormalities
Time frame: From Day 1(first dose) to Day7
The severity of electrocardiogram (ECG) abnormalities
The severity of QT interval abnormalities
Time frame: From Day 1(first dose) to Day7
The Number of participants with electrocardiogram (ECG) abnormalities
The Number of participants with QT interval abnormalities
Time frame: From Day 1(first dose) to Day7
The severity of electrocardiogram (ECG) abnormalities
The severity of QTcF abnormalities
Time frame: From Day 1(first dose) to Day7
The Number of participants with electrocardiogram (ECG) abnormalities
The Number of participants with QTcF abnormalities
Time frame: From Day 1(first dose) to Day7