Clinical trial NCT05917964: A Food Effect Study of LP-168 Tablets in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mantle Cell Lymphoma
Lead sponsor: Guangzhou Lupeng Pharmaceutical Company LTD.
Sponsor class: INDUSTRY
First posted: 2023-06-26
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: PK Parameter AUC0-t
timeFrame: Up to 72 hours post last dose
measure: PK Parameter AUC0-∞
timeFrame: Up to 72 hours post last dose
measure: PK Parameter Cmax
timeFrame: Up to 72 hours post last dose
measure: PK Parameter Tmax
timeFrame: Up to 72 hours post last dose
Secondary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events as determined by CTCAE v5.0
timeFrame: From the first dose of the study drug to 4 days after last dose]
measure: Severity of Treatment Emergent Adverse Events as determined by CTCAE v5.0
timeFrame: From the first dose of the study drug to 4 days after last dose]
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Honggang Lou, MS
role: PRINCIPAL_INVESTIGATOR
References: