A Single and Multiple Dose Pharmacokinetic Study of Dotinurad in Chinese Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Single-dose Part, AUC0-24h: Area Under the Concentration-time Curve From Zero Time to 24 hours for Dotinurad
研究概览
简要总结
The primary purpose of this study is to evaluate the pharmacokinetics (PK) of dotinurad following single and multiple oral doses of dotinurad in Chinese healthy male and female participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •Healthy Chinese participants living in China.
- •Non-smoking, male or female, age greater than or equal to (>=) 18 years and less than or equal to (<=) 45 years old at the time of informed consent.
- •Participants with serum uric acid level less than >=5.5 milligrams per decilitre (mg/dL) at Screening (Cohort B only).
排除标准
- •Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [β-hCG] or human chorionic gonadotropin [hCG] test). A separate baseline assessment of serum β-hCG (or hCG) or urine pregnancy test is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
- •Females of childbearing potential.
- •Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing.
- •Evidence of disease that may influence the outcome of the study within 4 weeks before dosing; example, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism.
- •Any history of gastrointestinal surgery that may affect PK profiles of dotinurad, example, hepatectomy, nephrectomy, digestive organ resection at Screening.
研究组 & 干预措施
Cohort A Single Dose: Dotinurad
Participants will receive dotinurad 1 milligram (mg) (1*1 mg tablet) as a single oral dose after 10-hour fasting on Day 1 in the morning.
干预措施: Dotinurad (Drug)
Cohort B Multiple Dose: Dotinurad
Participants will receive dotinurad 4 mg (2*2 mg tablets) as a single oral dose after 10-hour fasting on Day 1 in the morning. A washout period of 3 days will be maintained after single dose on Day 1 and then participants will receive dotinurad 4 mg (2*2 mg tablets) after 10-hour fasting from Day 4 to Day 10 once daily in the morning.
干预措施: Dotinurad (Drug)
Cohort C Single Dose: Dotinurad
Participants will receive dotinurad 10 mg (5*2 mg tablets) as a single oral dose after 10-hour fasting on Day 1 in the morning.
干预措施: Dotinurad (Drug)
结局指标
主要结局
Single-dose Part, AUC0-24h: Area Under the Concentration-time Curve From Zero Time to 24 hours for Dotinurad
时间窗: Day 1: 0-24 hours post dose
Multiple-dose Part, Rac(Cmax): Accumulation Ratio for Cmax
时间窗: Day 10: 0-72 hours post dose
Single-dose Part, Tmax: Time at Which the Highest Drug Concentration Occurs for Dotinurad
时间窗: Day 1: 0-48 hours post dose
Single-dose Part, Vz/F: Apparent Volume of Distribution at Terminal Phase for Dotinurad
时间窗: Day 1: 0-48 hours post dose
Single-dose Part, t1/2: Terminal Elimination Phase Half-life for Dotinurad
时间窗: Day 1: 0-48 hours post dose
Single-dose Part, AUC0-t: Area Under the Concentration-time Curve From Zero Time to Time of Last Quantifiable Concentration for Dotinurad
时间窗: Day 1: 0-48 hours post dose
Single-dose Part, AUC0-inf: Area Under the Concentration-time Curve From Zero Time Extrapolated to Infinite Time for Dotinurad
时间窗: Day 1: 0-48 hours post dose
Single-dose Part, kel: Elimination Rate Constant for Dotinurad
时间窗: Day 1: 0-48 hours post dose
Multiple-dose Part, tss,max: Time at Which the Highest Drug Concentration Occurs at Steady State for Dotinurad
时间窗: Day 10: 0-72 hours post dose
Single-dose Part, Cmax: Maximum Observed Concentration for Dotinurad
时间窗: Day 1: 0-48 hours post dose
Multiple-dose Part, t1/2: Terminal Elimination Phase Half-life for Dotinurad
时间窗: Day 10: 0-72 hours post dose
Multiple-dose Part, AUC0-τ: Area Under the Concentration-time Curve Over the Dosing Interval on Multiple Dosing for Dotinurad
时间窗: Day 10: 0-72 hours post dose
Single-dose Part, CL/F: Apparent Total Clearance Following Oral Administration for Dotinurad
时间窗: Day 1: 0-48 hours post dose
Single-dose Part, MRT0-t: Mean Residence Time From Zero Time to Time of Last Quantifiable Concentration on Single Dose for Dotinurad
时间窗: Day 1: 0-48 hours post dose
Multiple-dose Part, Css,max: Maximum Observed Concentration at Steady State for Dotinurad
时间窗: Day 10: 0-72 hours post dose
Multiple-dose Part, Css,av: Average Steady-state Concentration for Dotinurad
时间窗: Day 10: 0-72 hours post dose
Multiple-dose Part, Vz/F: Apparent Volume of Distribution at Terminal Phase for Dotinurad
时间窗: Day 10: 0-72 hours post dose
Multiple-dose Part, kel: Elimination Rate Constant for Dotinurad
时间窗: Day 10: 0-72 hours post dose
Multiple-dose Part, Rac(AUC0-24h): Accumulation Ratio for AUC(0-24h)
时间窗: Day 10: 0-24 hours post dose
Multiple-dose Part, Css,min: Minimum Observed Concentration at Steady State for Dotinurad
时间窗: Day 10: 0-72 hours post dose
Multiple-dose Part, CLss/F: Apparent Total Clearance Following Oral Administration at Steady State for Dotinurad
时间窗: Day 10: 0-72 hours post dose
Multiple-dose Part, MRT: Mean Residence Time for Dotinurad
时间窗: Day 10: 0-72 hours post dose
Multiple-dose Part, PTF: Peak-trough Fluctuation
时间窗: Day 10: 0-72 hours post dose
次要结局
未报告次要终点