A Food Effect Study of LP-168 Tablets in Healthy Subjects

Mantle Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05917964
• Other study ID #: LP-168-CN103
• Status: Completed
• Phase: Phase 1
• Start date: June 21, 2023
• Est. completion date: August 21, 2023

Study information

• Verified date: September 2023
• Source: Guangzhou Lupeng Pharmaceutical Company LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 21, 2023
• Est. primary completion date: August 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma

Intervention

Drug:
• LP-168 tablet
LP-168 is a small molecule kinase inhibitor that is administered once daily via oral administration

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Lupeng Pharmaceutical Company LTD.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 72 hours post last dose
Primary	PK Parameter AUC0-8	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	Up to 72 hours post last dose
Primary	PK Parameter Cmax	Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration of LP-168	Up to 72 hours post last dose
Primary	PK Parameter Tmax	PK As Assessed By Time To Maximum Observed Plasma Concentration of LP-168	Up to 72 hours post last dose
Secondary	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]
Secondary	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]