The primary objective of the study is to evaluate the effect of high-fat diet on pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR1459 tablets. The secondary objective of the study is to evaluate the safety of single dose of SHR1459 orally in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
28
SHR1459 administration in fasted condition in period 1, SHR1459 administration after high-fat diet in period 2
SHR1459 administration after high-fat diet in period 1, SHR1459 administration in fasted condition in period 2
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical College
Nanjing, Jiangsu, China
Pharmacokinetics parameter: Cmax of SHR1459
Peak Plasma Concentration (Cmax) of SHR1459
Time frame: through study completion, an average of 23 days
Pharmacokinetics parameter: AUC of SHR1459
Area under the plasma concentration versus time curve (AUC) of SHR1459
Time frame: through study completion, an average of 23 days
Pharmacokinetics parameter: Tmax of SHR1459
Time of maximum observed concentration (Tmax) of SHR1459
Time frame: through study completion, an average of 23 days
Pharmacokinetics parameter: T1/2 of SHR1459
Half time (T1/2) of SHR1459
Time frame: through study completion, an average of 23 days
Pharmacokinetics parameter: CL/F of SHR1459
Total body clearance for extravascular administration (CL/F) of SHR1459
Time frame: through study completion, an average of 23 days
Pharmacokinetics parameter: Vz/F of SHR1459
Volume of distribution (Vz/F) of SHR1459
Time frame: through study completion, an average of 23 days
Number of patients with Adverse Events (AEs)
To assess the adverse events according to CTCAE5.0
Time frame: through study completion, an average of 23 days
Vital sign (Blood pressure [BP])
To assess the vital signs as a criteria of safety and tolerability variables.
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Time frame: through study completion, an average of 23 days
Vital sign (pulse)
To assess the vital signs as a criteria of safety and tolerability variables.
Time frame: through study completion, an average of 23 days
Vital sign (temperature)
To assess the vital signs as a criteria of safety and tolerability variables.
Time frame: through study completion, an average of 23 days
Resting and digital electrocardiograms (ECGs)
To assess the cardiovascular system functioning as a criteria of safety and tolerability variables.
Time frame: through study completion, an average of 23 days
Physical examination
To assess the physical conditions as a criteria of safety and tolerability variables.
Time frame: through study completion, an average of 23 days
Laboratory assessments
To assess the hematology, clinical chemistry and urinalysis as a criteria of safety and tolerability variables.
Time frame: through study completion, an average of 23 days