NCT05070195已完成1 期
A Single-center, Open-label, Phase I Drug-drug Interaction Clinical Study to Investigate the Effect of SKLB1028 on the Pharmacokinetics of Midazolam in Healthy Subjects
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2021年6月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Maximum concentration (Cmax)of Midazolam and its metabolite 1'-OH-midazolam
研究概览
简要总结
This is a single-center, open-label phase I clinical study to investigate the effect of SKLB1028 on the pharmacokinetics of Midazolam and its metabolite 1'-OH-midazolam in healthy subjects. This study also aims to evaluate the safety and tolerability of SKLB1028 in the presence of Midazolam.
详细描述
This study aims to characterize the drug-drug Interactions (DDI) potential of SKLB1028 with the sensitive index substrate drug (Midazolam) in Healthy Subjects. The study consists of a screening period (Day -14 to Day -2), a baseline period (Day -1), a treatment period, and a follow-up visit period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects:
- •Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions;
- •18 ≤ age ≤45, male;
- •Subjects with weight ≥50.0 kg and body mass index (BMI) 19-26 kg/m^2 (inclusive);
- •Subjects are willing to use effective non-hormonal contraceptives such as sexual abstinence, and not allowed to donate sperm from screening to the 6 months after the last dose administration unless permanent contraception has been taken, such as vasectomy;
- •Ability to communicate well with researchers, and be willing to comply with all trial requirements.
排除标准
- •Allergic constitution, including a history of allergy to any of the study drugs or other similarly structured drugs;
- •Previous or current severe diseases, such as cardiovascular, respiratory, gastrointestinal, endocrine, hematological, psychiatric/neurological systems diseases, or any other disease that can interfere with the results of the study;
- •Subjects with sleep apnea syndrome;
- •Subjects with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption;
- •Subjects with acute angle closure glaucoma;
- •Subjects who have previously undergone surgery that may affect the absorption, distribution, metabolism, or excretion of the drug (e.g., subtotal gastrectomy), or who have a scheduled surgical plan during the study period;
- •Use of any inhibitors or inducers of CYP3A4, or any strong inhibitors or inducers of CYP2C8 or P-gp within 2 weeks prior to screening;
- •Use of any prescription drug, over-the-counter drug, herbal medicine or health products within 2 weeks prior to screening;
- •History of drug abuse within 1 year prior to screening, or positive urine drug screen at screening;
- •Smoking more than 5 cigarettes per day within 6 months prior to screening;
- •Average daily intake of alcohol more than 14 units (14 units ≈285 mL of beer, or 25 mL of liquor, or 150 mL of wine) within 4 weeks prior to screening, or a positive ethanol breath test at screening;
- •Consumption of grapefruit juice, methylxanthine-rich food or beverage (such as coffee, tea, cola, chocolate, energy drinks) within 48 h before the administration, or those who have had strenuous exercise, or have other factors affecting absorption, distribution, metabolism, excretion, etc of the drug;
- •Subjects who have received vaccinations within 4 weeks prior to screening;
- •Participation in another clinical trial within 3 months before screening (whichever is administrated);
- •Blood donation (or blood loss) ≥200 mL within 4 weeks prior to the screening, or who have a blood donation plan during the entire study or within 1 months after the study;
- •Any abnormalities of clinical significance in physical examination, vital signs, clinical laboratory tests (routine blood test, blood biochemistry, routine urine test, coagulation function), anteroposterior chest radiograph or chest CT scan;
- •Abnormalities of clinical significance in 12-lead ECG examination (such as tachycardia/bradycardia in need of medical treatment, II-III degree atrioventricular block, QTcF>450 ms or any other clinically significant abnormalities);
- •Any positive test result of hepatitis B surface antigen or hepatitis C virus antibody, or subjects with a history of hepatitis B;
- •Any positive test result of anti-human immunodeficiency virus antibody or anti-Treponema pallidum specific antibody;
- •Subjects with a history of fainting needle or blood, cannot tolerate vein puncture for blood collection;
- •Any condition that, in the opinion of the Investigator, may prevent the subject from completing the study or pose a significant risk to the subject.
研究组 & 干预措施
The DDI of SKLB1028 and Midazolam
Experimental
Eligible subjects received a single dose of Midazolam 15 mg on Day 1, and took a single dose of Midazolam 15 mg and a single dose of SKLB1028 150 mg with dosing interval of 0.5 h on Day 3.
干预措施: SKLB1028 (Drug)
The DDI of SKLB1028 and Midazolam
Experimental
Eligible subjects received a single dose of Midazolam 15 mg on Day 1, and took a single dose of Midazolam 15 mg and a single dose of SKLB1028 150 mg with dosing interval of 0.5 h on Day 3.
干预措施: Midazolam (Drug)
结局指标
主要结局
Maximum concentration (Cmax)of Midazolam and its metabolite 1'-OH-midazolam
时间窗: Day 1 and Day 3(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hrs post-dose)
Area under the concentration-time curve (AUC) from 0 to the last measurable concentration (AUC0-t) of Midazolam and its metabolite 1'-OH-midazolam
时间窗: Day 1 and Day 3(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hrs post-dose)
AUC extrapolated to infinity (AUCinf) of Midazolam and its metabolite 1'-OH-midazolam
时间窗: Day 1 and Day 3(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hrs post-dose)
次要结局
- Time to Cmax (Tmax) of Midazolam and its metabolite 1'-OH-midazolam(Day 1 and Day 3(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hrs post-dose))
- Clinically significant changes from baseline in blood biochemistry test were recorded as AEs at each visit time point.(Throughout the study period, with an average of 10 days)
- Clinically significant changes from baseline in routine urine test were recorded as AEs at each visit time point.(Throughout the study period, with an average of 10 days)
- Clinically significant changes from baseline in coagulation function test were recorded as AEs at each visit time point.(Throughout the study period, with an average of 10 days)
- Terminal elimination half-life (t1/2) of Midazolam and its metabolite 1'-OH-midazolam(Day 1 and Day 3(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hrs post-dose))
- Apparent volume of distribution (Vz/F) of Midazolam(Day 1 and Day 3(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hrs post-dose))
- Clinically significant changes from baseline in vital signs examination were recorded as AEs at each visit time point.(Throughout the study period, with an average of 10 days)
- Apparent Clearance (CLz/F) of Midazolam(Day 1 and Day 3(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hrs post-dose))
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(Throughout the study period, with an average of 10 days)
- Clinically significant changes from baseline in routine blood test were recorded as AEs at each visit time point.(Throughout the study period, with an average of 10 days)
- Clinically significant changes from baseline in 12-lead electrocardiogram (ECG) examination were recorded as AEs at each visit time point.(Throughout the study period, with an average of 10 days)
- Clinically significant changes from baseline in physical examination were recorded as AEs at each visit time point.(Throughout the study period, with an average of 10 days)
研究者
研究点 (1)
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