NCT06255951已完成1 期
This is a Single-center, Two-sequence, Open-label, Two-cycle Drug-drug Interaction (DDI) Study in Healthy Subjects. To Evaluate the Effects of Itraconazole Capsules, a Strong Inhibitor of CYP3A4, and Rifampicin Capsules, a Strong Inducer, on the Pharmacokinetics of TY-9591 Tablets After a Single Oral Dose
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve from 0 to the last quantifiable time point after dose administration (AUC0-t)
研究概览
简要总结
Studies evaluating the effects of itraconazole or rifampicin on the pharmacokinetics of TY-9591 tablets in healthy subjects
详细描述
To evaluate the pharmacokinetics of TY-9591 tablets in healthy Chinese subjects after a single oral administration. To evaluate the effects of itraconazole/rifampicin on the pharmacokinetics of TY-9591 and its metabolites D1 and D2 after oral administration of TY-9591 tablets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female healthy adult subjects aged 18-45 years old (inclusive), in which male or female accounted for no less than 1/4 of the total number of subjects in each sequence.
- •Body mass index (BMI) between 19.0 and 26.0 kg/m2 [BMI= weight (kg)/ height 2 (m2)] (including boundary values).
- •Participants (including male participants) were infertile themselves, or agreed to use highly effective nonpharmacologic contraceptive methods or abstain completely from sex for 6 months after the last dose of self-medication.
- •Subjects voluntarily participated and signed an informed consent form.
- •Subjects had good communication with investigators and were able to complete the trial in accordance with the protocol.
排除标准
- •Those with clinically significant abnormalities in physical examination, vital signs, routine laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function), 12-lead electrocardiogram, ophthalmic examination, abdominal color Doppler ultrasound (liver, bile duct, pancreas, spleen, kidney), etc.
- •Persons with one or more positive results of human immunodeficiency virus (HIV) antibody, hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) antibody, or treponema pallidum antibody (Anti-TP).
- •smokers with an average of more than 10 cigarettes per day in the previous 3 months or habitual users of nicotine products who could not quit during the study.
- •Heavy drinking or regular drinking in the 3 months before the screening period, i.e. drinking more than 14 units of alcohol per week (1 unit =360 mL of beer or 45 mL of 40% spirits or 150 mL of wine); Or alcohol breath test results on admission > 0.0 mg/100 mL and those who could not abstain from alcohol during the experiment.
- •those who consumed excessive amounts of tea, coffee, and/or caffeinated beverages (average > 8 cups/day, 250 mL/cup) in the 3 months before the screening period, and those who could not stop using them during the study period.
- •those who took dragon fruit, mango, grapefruit, chocolate, any food or beverage containing caffeine, diet rich in xanthine, and other special diets affecting drug absorption, distribution, metabolism, and excretion within 7 days before taking the drug.
- •Use of any drugs that inhibit or induce the liver CYP3A4 enzyme (see Appendix II), herbs, or foods containing herbal ingredients within 30 days before the screening period.
- •taking any medicine (including Chinese herbal medicine and health supplements) within 14 days before taking the test drug.
- •enrollment in any drug clinical trial within 3 months before the screening period.
- •Subjects who may not be able to complete the study for other reasons or who are considered unsuitable for the study by the investigators.
研究组 & 干预措施
Itraconazole
Experimental
Itraconazole
干预措施: Itraconazole (Drug)
Rifampicin
Experimental
Rifampicin
干预措施: Rifampicin (Drug)
结局指标
主要结局
Area under the concentration-time curve from 0 to the last quantifiable time point after dose administration (AUC0-t)
时间窗: through study completion,an average of 6 months
Area under the concentration-time curve from 0 to the last quantifiable time point after dose administration (AUC0-t)
Area under the concentration-time curve from 0 to infinity (AUC0-inf), as data permit
时间窗: through study completion,an average of 6 months
Area under the concentration-time curve from 0 to infinity (AUC0-inf), as data permit
Peak plasma concentrations (Cmax) of TY-9591 and its metabolites D1 and D2
时间窗: through study completion,an average of 6 months
Peak plasma concentrations (Cmax) of TY-9591 and its metabolites D1 and D2
次要结局
- Time to peak concentration (Tmax) of TY-9591 and its metabolites D1 and D2(through study completion,an average of 6 months)
- mean retention time (MRT) of TY-9591 and its metabolites D1 and D2(through study completion,an average of 6 months)
- The half-life of elimination phase (t1/2) of TY-9591 and its metabolites D1 and D2(through study completion,an average of 6 months)
- apparent clearance rate (CL/F) of TY-9591 and its metabolites D1 and D2(through study completion,an average of 6 months)
- apparent volume of distribution (Vd/F) of TY-9591 and its metabolites D1 and D2(through study completion,an average of 6 months)
- AUC ratio of metabolites to original drug(through study completion,an average of 6 months)
- Cmax ratio of metabolites to original drug(through study completion,an average of 6 months)
- elimination rate constant (λz) of TY-9591 and its metabolites D1 and D2(through study completion,an average of 6 months)
研究者
研究点 (1)
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