Effect of Food on the Pharmacokinetics of XZP-3287 in Healthy Subjects

Study Overview
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Brief Summary
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This study will be a randomized 3-treatment, cross-over study to evaluate the bioavailability of XZP-3287 administered after a high or low-fat meal.

Official Title
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A Phase I Study to Examine the Effects of Low and High-fat Meals on Orally Administered XZP-3287 in Healthy Adult Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: XZP-3287
* Drug: XZP-3287
* Drug: XZP-3287
* Drug: XZP-3287
* Drug: XZP-3287
* Drug: XZP-3287


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria Healthy male or female subjects aged 18 to 65 years (including 18 and 65); Male body weight ≥50kg, female body weight ≥45kg, body mass index between 18 to 28 kg/m2 (inclusive). No medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system. Subjects shall ake effective contraceptive measures voluntarily within 3 months from the date of signing the informed consent form (for women, 2 weeks before trial screening) to the date of the last medication. Willing and able to comply with all scheduled visits, study procedures, and provides written informed consent Exclusion Criteria: Allergic constitution and those with known allergy to XZP-3287 or similar drugs and excipients Abnormal clinical tests and clinical significance judged by the investigator Frequent use of sedatives, sleeping pills or other addictive drugs within 6 months before enrollment History of drug use, or drug abuse screening positive Those who had smoked more than 5 cigarettes per day on average in the 3 months before the screening period or habitually used nicotine-containing products and were unable to quit during the test period Heavy drinking or regular drinking in the six months preceding the screening period Use of any prescription drug or Chinese herbal medicine within 4 weeks prior to enrollment, or use of any over-the-counter drug, any vitamin product, health care drug within 14 days prior to enrollment; Treatment with an investigational drug within 3 months Participated in blood donation with blood donation volume ≥400 mL or received blood transfusion within 3 months before screening. Had a severe infection, trauma or major surgery within 4 weeks of screening Gastrointestinal disorders causing clinically significant symptoms such as nausea, vomiting, and diarrhea, or malabsorption syndromes Pregnant or lactating women, or subjects cannot take strict contraceptive measures as required. Hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antibody and syphilis antibody, any of which are positive. Allergic to any food ingredients or has special requirements on diet, cannot follow the unified diet habitual consumption of food or beverage containing methylxanthine, such as tea, coffee, cola, chocolate and so on during the study period habitual consumption of grapefruit juice during the study period have difficulty in blood collection or cannot tolerate vein puncture for blood collection As determined by the investigator, the subject has other factors that are not suitable for the study -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Cycle1 Day 1：fasting；Cycle2 Day 1：high-fat meal；Cycle3 Day 1：low-fat meal | Drug: XZP-3287<br>* Cycle1 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast<br>|
| Experimental: Arm B<br>Cycle1 Day 1：high-fat meal；Cycle2 Day 1：low-fat meal；Cycle3 Day 1：fasting | Drug: XZP-3287<br>* Cycle1 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 before starting a low-fat breakfast<br>|
| Experimental: Arm C<br>Cycle1 Day 1：low-fat meal；Cycle2 Day 1：fasting；Cycle3 Day 1：high-fat meal | Drug: XZP-3287<br>* Cycle1 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast<br>|
| Experimental: Arm D<br>Cycle1 Day 1：fasting；Cycle2 Day 1：low-fat meal；Cycle3 Day 1：high-fat meal | Drug: XZP-3287<br>* Cycle1 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast<br>|
| Experimental: Arm E<br>Cycle1 Day 1：high-fat meal；Cycle2 Day 1：fasting；Cycle3 Day 1：low-fat meal | Drug: XZP-3287<br>* Cycle1 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle2 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast<br>|
| Experimental: Arm F<br>Cycle1 Day 1：low-fat meal；Cycle2 Day 1：high-fat meal；Cycle3 Day 1：fasting | Drug: XZP-3287<br>* Cycle1 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle3 Day 1: one dose of XZP-3287 before starting a low-fat breakfast<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary PK Endpoints | Cmax | day 1 day 21 | 
| Primary PK Endpoints | AUC0-∞ | day 1 day 21 | 
| Primary PK Endpoints | AUC0-t | day 1 day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary PK measures | Tmax | day 1 day 21 | 
| Secondary PK measures | T1/2 | day 1 day 21 | 
| Secondary PK measures | CL/F | day 1 day 21 | 
| Secondary PK measures | Vz/F | day 1 day 21 | 
| Safety and tolerability | Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0 | Up to 14 days after last dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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XZP-3287, Food Effect, Pharmacokinetics