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

Primary Purpose

Mantle Cell Lymphoma

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
LP-168 tablet
Sponsored by
Guangzhou Lupeng Pharmaceutical Company LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mantle Cell Lymphoma

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Arm Type

Experimental

Experimental

Arm Label

Cohort A (fasted-fed)

Cohort B (fed-fasted)

Arm Description

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.

Outcomes

Primary Outcome Measures

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
PK Parameter AUC0-∞
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
Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration of LP-168
PK Parameter Tmax
PK As Assessed By Time To Maximum Observed Plasma Concentration of LP-168

Secondary Outcome Measures

Number of Participants With Treatment Emergent Adverse Events as determined by CTCAE v5.0
Severity of Treatment Emergent Adverse Events as determined by CTCAE v5.0

Full Information

First Posted
June 15, 2023
Last Updated
September 8, 2023
Sponsor
Guangzhou Lupeng Pharmaceutical Company LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT05917964
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 21, 2023 (Actual)
Primary Completion Date
August 21, 2023 (Actual)
Study Completion Date
August 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangzhou Lupeng Pharmaceutical Company LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mantle Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort A (fasted-fed)
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort B (fed-fasted)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
LP-168 tablet
Other Intervention Name(s)
NWP-775
Intervention Description
LP-168 is a small molecule kinase inhibitor that is administered once daily via oral administration
Primary Outcome Measure Information:
Title
PK Parameter AUC0-t
Description
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
Time Frame
Up to 72 hours post last dose
Title
PK Parameter AUC0-∞
Description
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
Time Frame
Up to 72 hours post last dose
Title
PK Parameter Cmax
Description
Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration of LP-168
Time Frame
Up to 72 hours post last dose
Title
PK Parameter Tmax
Description
PK As Assessed By Time To Maximum Observed Plasma Concentration of LP-168
Time Frame
Up to 72 hours post last dose
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events as determined by CTCAE v5.0
Time Frame
From the first dose of the study drug to 4 days after last dose]
Title
Severity of Treatment Emergent Adverse Events as determined by CTCAE v5.0
Time Frame
From the first dose of the study drug to 4 days after last dose]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Honggang Lou, MS
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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