A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Single and Multiple Oral Doses Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of TAK-279 in Healthy Chinese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of TAK-279
研究概览
简要总结
The main aim of this study is to find out how the body of a healthy Chinese adult processes TAK-279 (pharmacokinetics). Other aims are to learn about side effects and how well TAK-279 is tolerated when given to healthy Chinese Adults. Participants will receive either TAK-279 or a placebo on Day 1 and from Day 6 to Day 19. Blood samples will be taken at different timepoints throughout the study participation. Participants will need to adhere to certain lifestyle restrictions during the study. This also includes eating and drinking restrictions.
During the study, participants will need to stay at the clinic for 25 days.
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
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1 and 2: Placebo 30 mg or 60 mg
Participants will receive TAK-279 30 mg or 60 mg (2*30mg) matching placebo oral tablets on Day 1 followed by Day 6 to Day 19 once daily under fasted condition.
干预措施: Placebo (Drug)
Cohort 1: TAK-279 30 mg
Participants will receive a single dose of TAK-279 30 milligram (mg) oral tablet on Day 1 followed by Day 6 to Day 19 once daily under fasted condition.
干预措施: TAK-279 (Drug)
Cohort 2: TAK-279 60 mg
Participants will receive a dose of TAK-279 60 mg (2*30mg) oral tablets on Day 1 followed by Day 6 to Day 19 once daily under fasted condition.
干预措施: TAK-279 (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of TAK-279
时间窗: Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose
Cmax of TAK-279 in plasma will be assessed.
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of TAK-279
时间窗: Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose
Cmax,ss of TAK-279 in plasma will be assessed.
Area Under the Concentration-time Curve From Time 0 To Infinity (AUC0-inf) of TAK-279
时间窗: Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose
AUC0-inf of TAK-279 in plasma will be assessed.
Area Under the Concentration Time Curve From Time 0 to the Time t (AUC0-t) of TAK-279
时间窗: Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose
AUC0-t of TAK-279 in plasma will be assessed.
Area Under the Concentration-Time Curve During a Dosing Interval (AUCtau) of TAK-279
时间窗: Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose
AUCtau of TAK-279 in plasma will be assessed.
次要结局
- Average Plasma Concentration (Cavg) for TAK-279(Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose)
- Accumulation Ratio for Cmax (RA, Cmax) of TAK-279(Day 1 and Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose)
- Accumulation Ratio for AUCtau (RA, AUCtau) of TAK-279(Day 1 and Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose)
- Number of Participants With Clinically Significant Changes in 12-Lead Electrocardiogram (ECG), Vital Signs and Clinical Laboratory Parameters(From start of study drug administration up to follow-up (up to Day 36))
- Terminal phase half-life (t1/2) of TAK-279 at Day 1 and Day 19(Day 1 and Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose)
- Trough Concentration (Ctrough) of TAK-279(Pre-dose on Day 17, Day 18 and Day 19)
- Apparent Volume of Distribution at Steady State (Vss/F) of TAK-279(Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose)
- Minimum Plasma Concentration (Cmin) of TAK-279(Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose)
- Terminal Elimination Rate Constant (Lambda z) of TAK-279 at Day 1 and Day 19(Day 1 and Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose)
- Apparent Clearance (CL/F) of TAK-279(Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose)
- Time to Reach the Maximum Plasma Concentration at Steady State (Tmax,ss) of TAK-279(Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose)
- Total Body Drug Clearance at Steady State (CLss/F) of TAK-279(Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose)
- Percent peak-to-trough fluctuation (%FLUC) of TAK-279(Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESI)(From start of study drug administration up to follow-up (up to Day 36))
- Area Under the Plasma Concentration-Time Curve From Time 0 To the Time 24 Hours (AUC0-24) of TAK-279(Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose)
- Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of TAK-279(Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose)
- Time to Reach Peak Plasma Concentration (Tmax) of TAK-279(Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose)