Clinical trial NCT04951765: Effect of Food on the Pharmacokinetics of XZP-3287 in Healthy Subjects
Official title: A Phase I Study to Examine the Effects of Low and High-fat Meals on Orally Administered XZP-3287 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Keywords: XZP-3287
Food Effect
Pharmacokinetics
Lead sponsor: Xuanzhu Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-07-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

Inclusion Criteria

1. Healthy male or female subjects aged 18 to 65 years (including 18 and 65);
2. Male body weight ≥50kg, female body weight ≥45kg, body mass index between 18 to 28 kg/m2 (inclusive).
3. No medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.
4. 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.
5. Willing and able to comply with all scheduled visits, study procedures, and provides written informed consent

Exclusion Criteria:

1. Allergic constitution and those with known allergy to XZP-3287 or similar drugs and excipients
2. Abnormal clinical tests and clinical significance judged by the investigator
3. Frequent use of sedatives, sleeping pills or other addictive drugs within 6 months before enrollment
4. History of drug use, or drug abuse screening positive
5. 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
6. Heavy drinking or regular drinking in the six months preceding the screening period
7. 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;
8. Treatment with an investigational drug within 3 months
9. Participated in blood donation with blood donation volume ≥400 mL or received blood transfusion within 3 months before screening.
10. Had a severe infection, trauma or major surgery within 4 weeks of screening
11. Gastrointestinal disorders causing clinically significant symptoms such as nausea, vomiting, and diarrhea, or malabsorption syndromes
12. Pregnant or lactating women, or subjects cannot take strict contraceptive measures as required.
13. Hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antibody and syphilis antibody, any of which are positive.
14. Allergic to any food ingredients or has special requirements on diet, cannot follow the unified diet
15. habitual consumption of food or beverage containing methylxanthine, such as tea, coffee, cola, chocolate and so on during the study period
16. habitual consumption of grapefruit juice during the study period
17. have difficulty in blood collection or cannot tolerate vein puncture for blood collection
18. As determined by the investigator, the subject has other factors that are not suitable for the study -

Primary outcomes:
measure: Primary PK Endpoints
timeFrame: day 1~day 21
measure: Primary PK Endpoints
timeFrame: day 1~day 21
measure: Primary PK Endpoints
timeFrame: day 1~day 21
Secondary outcomes:
measure: Secondary PK measures
timeFrame: day 1~day 21
measure: Secondary PK measures
timeFrame: day 1~day 21
measure: Secondary PK measures
timeFrame: day 1~day 21
measure: Secondary PK measures
timeFrame: day 1~day 21
measure: Safety and tolerability
timeFrame: Up to 14 days after last dose
Other outcomes:
Locations:
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
Study officials:
References: