a food effect study of lp-168 tablets in healthy subjects

Conditions: Mantle Cell Lymphoma

Summary: 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.

Eligibility criteria:
inclusion criteria: * subjects have no history of serious digestive system, central nervous system, cardiovascular system, kidney, respiratory system, metabolism and endocrine, skeletal and muscular system, blood system disease and cancer * subjects (including partners) are willing to take effective contraception measures during study and within 3 months after last dose * male and female healthy subjects aged 18 to 55 years old * male subjects weigh ≥ 50 kg, and female subjects weigh ≥ 45 kg * subjects able to understand and comply with study requirements * willing to sign the informed consent exclusion criteria: * abnormal vital signs, physical examination or laboratory tests with clinical significance * abnormal ecg or echocardiography with clinical significance * hepatitis b virus, hepatitis c virus, hiv and syphilis test positive. covid-19 dna positive. * subjects who have taken any drugs or health care products within 14 or 28 days before administration the study drug * subjects who have consumed diets that may alter the activity of liver metabolic enzymes within 7 days before administration the study drug * subjects who have consumed tea or alcohol-containing food product within 24hrs before administration the study drug * subjects who have a history of dysphagia or condition may affect drug absorption, distribution, metabolism and excretion * female subjects are breastfeeding or pregnant * subjects who have a history of drug/ alcohol/ tobacco abuse * subjects who have had a blood donation or massive blood loss within three months before screening; or had surgery within six months before screening * subjects who have participated in other clinical trial within three months before screening * subjects have special dietary requirements or cannot tolerate a standard meal