A Food Effect Study of LP-168 Tablets in Healthy Subjects
- Conditions
- Mantle Cell Lymphoma
- Interventions
- Drug: LP-168 tablet
- Registration Number
- NCT05917964
- Lead Sponsor
- Guangzhou Lupeng Pharmaceutical Company LTD.
- Brief 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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cohort A (fasted-fed) LP-168 tablet 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 (fed-fasted) LP-168 tablet 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.
- Primary Outcome Measures
Name Time Method PK Parameter AUC0-t Up to 72 hours post last dose 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
PK Parameter Tmax Up to 72 hours post last dose PK As Assessed By Time To Maximum Observed Plasma Concentration of LP-168
PK Parameter AUC0-∞ Up to 72 hours post last dose 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
PK Parameter Cmax Up to 72 hours post last dose Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration of LP-168
- Secondary Outcome Measures
Name Time Method Severity of Treatment Emergent Adverse Events as determined by CTCAE v5.0 From the first dose of the study drug to 4 days after last dose] Number of Participants With Treatment Emergent Adverse Events as determined by CTCAE v5.0 From the first dose of the study drug to 4 days after last dose]
Trial Locations
- Locations (1)
Second Affiliated Hospital, School of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Second Affiliated Hospital, School of Medicine, Zhejiang University🇨🇳Hangzhou, Zhejiang, China