- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05917964
A Food Effect Study of LP-168 Tablets in Healthy Subjects
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 Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Zhejiang
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Hangzhou, Zhejiang, China, 310003
- Second Affiliated Hospital, School of Medicine, Zhejiang University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort A (fasted-fed)
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.
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LP-168 is a small molecule kinase inhibitor that is administered once daily via oral administration
Other Names:
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Experimental: Cohort B (fed-fasted)
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.
|
LP-168 is a small molecule kinase inhibitor that is administered once daily via oral administration
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PK Parameter AUC0-t
Time Frame: 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
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Up to 72 hours post last dose
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PK Parameter AUC0-∞
Time Frame: Up to 72 hours post last dose
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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
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Up to 72 hours post last dose
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PK Parameter Cmax
Time Frame: Up to 72 hours post last dose
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Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration of LP-168
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Up to 72 hours post last dose
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PK Parameter Tmax
Time Frame: Up to 72 hours post last dose
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PK As Assessed By Time To Maximum Observed Plasma Concentration of LP-168
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Up to 72 hours post last dose
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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]
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From the first dose of the study drug to 4 days after last dose]
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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]
|
From the first dose of the study drug to 4 days after last dose]
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Collaborators and Investigators
Investigators
- Principal Investigator: Honggang Lou, MS, Second Affiliated Hospital, School of Medicine, Zhejiang University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LP-168-CN103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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