A Food Effect Study of LP-168 Tablets in Healthy Subjects
Mantle Cell Lymphoma
About this trial
This is an interventional treatment trial for Mantle Cell Lymphoma
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
Sites / Locations
- Second Affiliated Hospital, School of Medicine, Zhejiang University
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Cohort A (fasted-fed)
Cohort B (fed-fasted)
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.