Effect of Food on the Pharmacokinetics of XZP-3287 in Healthy Subjects
A Phase I Study to Examine the Effects of Low and High-fat Meals on Orally Administered XZP-3287 in Healthy Adult Subjects
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: Cuilan Xiao
- Phone Number: 0086-13699167610
- Email: xiaocuilan@xuanzhubio.com
Study Locations
-
-
Shandong
-
Qingdao, Shandong, China
- Recruiting
- The Affiliated Hospital of Qingdao University
-
Contact:
- Yu Cao
- Phone Number: 0086-0532-82911767
- Email: Caoyu1767@126.com
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Arm A
Cycle1 Day 1:fasting;Cycle2 Day 1:high-fat meal;Cycle3 Day 1:low-fat meal
|
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
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
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
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
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
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
|
|
Experimental: Arm B
Cycle1 Day 1:high-fat meal;Cycle2 Day 1:low-fat meal;Cycle3 Day 1:fasting
|
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
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
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
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
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
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
|
|
Experimental: Arm C
Cycle1 Day 1:low-fat meal;Cycle2 Day 1:fasting;Cycle3 Day 1:high-fat meal
|
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
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
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
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
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
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
|
|
Experimental: Arm D
Cycle1 Day 1:fasting;Cycle2 Day 1:low-fat meal;Cycle3 Day 1:high-fat meal
|
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
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
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
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
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
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
|
|
Experimental: Arm E
Cycle1 Day 1:high-fat meal;Cycle2 Day 1:fasting;Cycle3 Day 1:low-fat meal
|
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
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
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
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
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
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
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Experimental: Arm F
Cycle1 Day 1:low-fat meal;Cycle2 Day 1:high-fat meal;Cycle3 Day 1:fasting
|
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
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
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
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
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
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
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary PK Endpoints
Time Frame: day 1~day 21
|
Cmax
|
day 1~day 21
|
|
Primary PK Endpoints
Time Frame: day 1~day 21
|
AUC0-∞
|
day 1~day 21
|
|
Primary PK Endpoints
Time Frame: day 1~day 21
|
AUC0-t
|
day 1~day 21
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Secondary PK measures
Time Frame: day 1~day 21
|
Tmax
|
day 1~day 21
|
|
Secondary PK measures
Time Frame: day 1~day 21
|
T1/2
|
day 1~day 21
|
|
Secondary PK measures
Time Frame: day 1~day 21
|
CL/F
|
day 1~day 21
|
|
Secondary PK measures
Time Frame: day 1~day 21
|
Vz/F
|
day 1~day 21
|
|
Safety and tolerability
Time Frame: Up to 14 days after last dose
|
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0
|
Up to 14 days after last dose
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
Other Study ID Numbers
- XZP-3287-1002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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