A Phase I Study of KC1036 on Pharmacokinetics to Assess the Effect of High Fat Diet in Chinese Adult Healthy Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK) profile: T1/2
研究概览
简要总结
The primary objective of the study was to assess the effect of High Fat Diet on the pharmacokinetics of KC1036 in Chinese adult healthy subjects.
详细描述
This is an open-label, randomized, two cycle self crossover experimental design study to assess the effect of High Fat Diet on the pharmacokinetics, material balance, safety of KC1036 in Chinese adult healthy subjects. This study was divided into two Groups A and B.
Group A：In the fasting state, KC1036 po only once (60mg QD) and after 7 days, in the high fat diet state, KC1036 po only once (60mg QD).
Group B：In the high fat diet state, KC1036 po only once (60mg QD) and after 7 days, in the fasting state, KC1036 po only once (60mg QD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •18~65 years of age, male.
- •The weight of male subject ≥50kg, 19≤BMI≤26g/m
- •Agree to take adequate contraceptive measures to prevent spouse pregnancy during the clinical trail.
- •Able to comprehend and willing to sign an informed consent form (ICF).
排除标准
- •Diseases such as liver, kidney, endocrine, cardiovascular, respiratory, nervous, mental, digestive tract, lung, immunity, skin, blood or metabolic disorders that are considered clinically significant by investigator, or have a history of these diseases, or have undergone major surgery, or factors that will endanger the safety of the subject or affect the research results.
- •Physical examination, vital signs, laboratory examination, 12-ECG and chest film are clinically significant.
- •Excessive smoking within 3 months before screening.
- •History of drug and food allergy.
- •Drinking 14 units of alcohol per week within 6 months prior dosing (1 unit = 360 mL of beer, or 150mL of wine).
- •Participate in blood donate blood volume≥200mL or blood loss ≥200mL within 3 month prior dosing.
- •Take any prescription, any over-the-counter medication, traditional Chinese medicines, vitamin products within14 days prior dosing.
- •Take any clinical trial drugs within 3 months prior dosing.
- •Dysphagia or history of gastrointestinal diseases affecting drug absorption.
- •Combined with other viral infections (anti-HCV, anti-HIV positive, anti-TP positive, HBsAg positive) or combined with syphilis infection.
- •Acute diseases requiring clinical treatment before screening or prior dosing.
- •Anyone who refuse to stop ingest foods or drinks containing caffeine, alcohol from 48 hours before dosing to the end of the study.
- •Urine drug positive or drug users within 3 months prior dosing.
- •The investigator believes that the subjects are not eligible to participate in this trial.
研究组 & 干预措施
Group A
In the fasting state, KC1036 po only once (60mg QD) and after 7 days，in the high fat diet state，KC1036 po only once (60mg QD).
干预措施: KC1036 (Drug)
Group B
In the high fat diet state, KC1036 po only once (60mg QD) and after 7 days, in the fasting state, KC1036 po only once (60mg QD).
干预措施: KC1036 (Drug)
结局指标
主要结局
Pharmacokinetics (PK) profile: T1/2
时间窗: up to 13 Days
Terminal half-life
Pharmacokinetics (PK) profile: Cmax
时间窗: up to 13 Days
Peak Plasma Concentration
Pharmacokinetics (PK) profile: Tmax
时间窗: up to 13 Days
Time to reach the maximum plasma concentration
Pharmacokinetics (PK) profile: AUC
时间窗: up to 13 Days
Area under the single-dose plasma concentration-time curve
次要结局
- Adverse events (AEs)(up to 43 Days)
- material balance(up to 13 Days)