This is a randomized, two-period, two-sequence two-treatment crossover design food effect study to evaluate the pharmacokinetic profile of LP-168 tablets in healthy subjects after single oral administration under fasted and fed conditions
A total of 22 subjects from Cohort A and Cohort B, with a single sex ratio of not less than 1/3, will be included in this study. Each subject will undergo two cycles of self-crossover dosing, respectively. 4 days of PK sample collection and safety observation period will be conducted after the first dose for the first cycle, followed by the 4-day second cycle of PK sample collection and safety observation. The washout period between the 2 doses will be 7 days. Subjects who voluntarily participate in the study and complete the informed consent process will be randomly assigned to the fasted-fed group (Cohort A) or the fed-fasted group (Cohort B) in a 1:1 ratio after completion of all screening visit examinations and after the investigator determines that all inclusion criteria are met and all exclusion criteria are not met. Cohort A was administered once in Cycle 1 Day1 under fasted condition and once in Cycle 2 Day1 (i.e., Day8 after Cycle 1 administration) under fed condition for a total of 2 doses; cohort B was administered once in Cycle 1 Day 1 under fed condition and once in Cycle 2 Day 1 (i.e., D8 after Cycle 1 administration) under fasted conditions for a total of 2 doses, both at a dose of 150 mg of LP-168 tablets.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
LP-168 is a small molecule kinase inhibitor that is administered once daily via oral administration
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
PK Parameter AUC0-t
PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To The Time of The Last Quantifiable Concentration Of LP-168
Time frame: Up to 72 hours post last dose
PK Parameter AUC0-∞
PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To The Time of Intersection of the extrapolated concentration-time curve and the time-axis Of LP-168 PK curve
Time frame: Up to 72 hours post last dose
PK Parameter Cmax
Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration of LP-168
Time frame: Up to 72 hours post last dose
PK Parameter Tmax
PK As Assessed By Time To Maximum Observed Plasma Concentration of LP-168
Time frame: Up to 72 hours post last dose
Number of Participants With Treatment Emergent Adverse Events as determined by CTCAE v5.0
Time frame: From the first dose of the study drug to 4 days after last dose]
Severity of Treatment Emergent Adverse Events as determined by CTCAE v5.0
Time frame: From the first dose of the study drug to 4 days after last dose]
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