NCT04951765Unknown1 期
A Phase I Study to Examine the Effects of Low and High-fat Meals on Orally Administered XZP-3287 in Healthy Adult Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Primary PK Endpoints
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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 -
研究组 & 干预措施
Arm A
Experimental
Cycle1 Day 1：fasting；Cycle2 Day 1：high-fat meal；Cycle3 Day 1：low-fat meal
干预措施: XZP-3287 (Drug)
Arm B
Experimental
Cycle1 Day 1：high-fat meal；Cycle2 Day 1：low-fat meal；Cycle3 Day 1：fasting
干预措施: XZP-3287 (Drug)
Arm C
Experimental
Cycle1 Day 1：low-fat meal；Cycle2 Day 1：fasting；Cycle3 Day 1：high-fat meal
干预措施: XZP-3287 (Drug)
Arm D
Experimental
Cycle1 Day 1：fasting；Cycle2 Day 1：low-fat meal；Cycle3 Day 1：high-fat meal
干预措施: XZP-3287 (Drug)
Arm E
Experimental
Cycle1 Day 1：high-fat meal；Cycle2 Day 1：fasting；Cycle3 Day 1：low-fat meal
干预措施: XZP-3287 (Drug)
Arm F
Experimental
Cycle1 Day 1：low-fat meal；Cycle2 Day 1：high-fat meal；Cycle3 Day 1：fasting
干预措施: XZP-3287 (Drug)
结局指标
主要结局
Primary PK Endpoints
时间窗: day 1~day 21
AUC0-t
次要结局
- Secondary PK measures(day 1~day 21)
- Safety and tolerability(Up to 14 days after last dose)
研究者
研究点 (1)
Loading locations...
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