A Phase I, Single-Centre, Open-Label, Parallel, Two Dose Level Study to Investigate the Pharmacokinetics, Safety, and Tolerability Following a Single Dose of Baloxavir Marboxil in Healthy Chinese Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Time to Maximum Plasma Concentration (Tmax)
研究概览
简要总结
This study will evaluate the pharmacokinetics, safety and tolerability of a single oral dose of baloxavir marboxil (40 mg or 80 mg) in healthy Chinese participants.
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
- 20 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chinese participants must have Chinese parents and grandparents, all of whom were born in China.
- •Healthy status as defined by absence of evidence of any active or chronic disease
- •Participants whose body weight is ≥50 to <80 kg and body mass index is ≥18.5 to <26 kg/m2
排除标准
- •Participants with a history of stomach, vagus nerve, or intestinal surgery (except for appendectomy)
- •Participants who have a history of allergic symptoms including food allergy (Note: Non-active allergic rhinitis will be allowed)
- •Participants who require chronic drug therapy or those who have used drugs within 3 days prior to screening or within 14 days prior to Day -1
- •Participants who have used alcohol-containing, caffeine-containing, grapefruit containing, or St. John's wort-containing products within 72 hours prior to Day -1
- •Participants who have used tobacco- or nicotine-containing products within 24 weeks prior to screening
- •Participants who have donated > 400 mL of blood within 12 weeks or > 200 mL of blood within 4 weeks prior to screening, or have donated any amount of blood between screening and Day -1
研究组 & 干预措施
Baloxavir Marboxil 40 mg
干预措施: Baloxavir Marboxil (Drug)
Baloxavir Marboxil 80 mg
干预措施: Baloxavir Marboxil (Drug)
结局指标
主要结局
Time to Maximum Plasma Concentration (Tmax)
时间窗: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose
Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.
Area Under the Concentration to Time Curve From Time 0 to Time t (AUC0-t)
时间窗: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose
Time t may be chosen as a time point where evaluable concentrations are available in at least 90% of participants. Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.
Apparent Total Oral Clearance (CL/F)
时间窗: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose
Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.
Maximum Plasma Concentration (Cmax)
时间窗: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose
Baloxavir marboxil and baloxavir concentrations were analyzed by validated Liquid Chromatography with tandem mass spectrometry (LC-MS/MS). Non-compartmental analysis was employed to estimate the PK parameters.
Area Under the Concentration to Time Curve From Time 0 to Infinity (AUC0-inf)
时间窗: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose
Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.
Area Under the Concentration to Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last)
时间窗: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose
Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.
Plasma Concentrations 24 (C24), 48 (C48), and 72 Hours (C72) Postdose
时间窗: 24, 48 and 72 hours postdose
Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.
Terminal Elimination Half-Life (T1/2)
时间窗: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose
Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.
Apparent Oral Volume of Distribution (Vz/F)
时间窗: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose
Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.
次要结局
- Percentage of Participants With Adverse Events (AEs)(Up to Day 15)