A Food Effect Study of LP-168 Tablets in Healthy Subjects
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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
- 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 Design
Arms and Interventions
| 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. |
Drug: LP-168 tablet
LP-168 is a small molecule kinase inhibitor that is administered once daily via oral administration
Other Names:
|
| 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. |
Drug: LP-168 tablet
LP-168 is a small molecule kinase inhibitor that is administered once daily via oral administration
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 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
- PK Parameter Tmax [Up to 72 hours post last dose]
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 [From the first dose of the study drug to 4 days after last dose]]
- 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]]
Eligibility Criteria
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
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Subjects (including partners) are willing to take effective contraception measures during study and within 3 months after last dose
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Male and female healthy subjects aged 18 to 55 years old
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Male subjects weigh ≥ 50 kg, and female subjects weigh ≥ 45 kg
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Subjects able to understand and comply with study requirements
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Willing to sign the informed consent
Exclusion Criteria:
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Abnormal vital signs, physical examination or laboratory tests with clinical significance
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Abnormal ECG or echocardiography with clinical significance
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Hepatitis B virus, Hepatitis C virus, HIV and syphilis test positive. COVID-19 DNA positive.
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Subjects who have taken any drugs or health care products within 14 or 28 days before administration the study drug
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Subjects who have consumed diets that may alter the activity of liver metabolic enzymes within 7 days before administration the study drug
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Subjects who have consumed tea or alcohol-containing food product within 24hrs before administration the study drug
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Subjects who have a history of dysphagia or condition may affect drug absorption, distribution, metabolism and excretion
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Female subjects are breastfeeding or pregnant
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Subjects who have a history of drug/ alcohol/ tobacco abuse
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Subjects who have had a blood donation or massive blood loss within three months before screening; or had surgery within six months before screening
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Subjects who have participated in other clinical trial within three months before screening
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Subjects have special dietary requirements or cannot tolerate a standard meal
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Second Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | China | 310003 |
Sponsors and Collaborators
- Guangzhou Lupeng Pharmaceutical Company LTD.
Investigators
- Principal Investigator: Honggang Lou, MS, Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LP-168-CN103