A Single-center, Single- and Multiple-Dose Phase 1 Study to Evaluate the Safety and Pharmacokinetics of TAK-114 in Healthy Adult Japanese and Caucasian Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 主要终点
- Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of TAK-114 following single and multiple ascending oral doses in healthy Japanese male participants.
详细描述
This is a phase 1, randomized, double-blind, placebo-controlled, single and multiple oral dose study in healthy Caucasian and Japanese male participants.
The study is composed of three parts, Single-dose Ascending Part, Food Effect Part and Multiple-dose Ascending Part. Single-dose Ascending Part and Multiple-dose Ascending Part are designed as a randomized, double-blind or open-label, placebo-controlled, sequential-cohort, ascending single or multiple oral dose study of TAK-114 or matched placebo. The Food Effect Part is designed as a randomized, open-label, 2-period crossover study of a single dose of TAK-114.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese participants:
- •Must be willing to provide written informed consent and in the investigator's opinion able to comply with the study protocol.
- •Is aged 20 to 45 years, inclusive.
- •Weighs at least 50 kilogram (kg) and have a body mass index (BMI) between 18.5 and 25.0 kilogram per square meter (kg/m^2).
- •Healthy Caucasian participants:
- •Must be willing to provide written informed consent and in the investigator's opinion able to comply with the study protocol.
- •Is aged 20 to 45 years, inclusive; are of Caucasian descent (born to Caucasian parents and grandparents and has lived outside original country for less than 5 years) and maintains their original diet and lifestyle.
- •Weighs at least 50 kg and have a body mass index between 18.5 and 30.0 kg/m2.
排除标准
- •Participants have a known hypersensitivity to any component of the formulation of TAK-114 or any herb medicine or supplement related to Indigo naturalis.
研究组 & 干预措施
Cohort 3A: TAK-114 50 mg
Orally, once
干预措施: TAK-114 10 mg capsule (Drug)
Cohort 3B: TAK-114 50 mg
Orally, once
干预措施: TAK-114 10 mg capsule (Drug)
Cohort 1A: TAK-114 10 mg
Orally, once only.
干预措施: TAK-114 10 mg capsule (Drug)
Cohort 1B: TAK-114 10 mg
Orally, once
干预措施: TAK-114 10 mg capsule (Drug)
Cohort 2A: TAK-114 20 mg
Orally, once
干预措施: TAK-114 10 mg capsule (Drug)
Cohort 2B: TAK-114 20 mg
Orally, once
干预措施: TAK-114 10 mg capsule (Drug)
Cohort 4a: TAK-114 20 mg
Period 1: Single-dose administration in a fasting state Period 2: Single-dose administration 30 minutes after breakfast
干预措施: TAK-114 10 mg capsule (Drug)
Cohort 4b: TAK-114 20 mg
Period 1: Single-dose administration 30 minutes after breakfast Period 2: Single-dose administration in a fasting state
干预措施: TAK-114 10 mg capsule (Drug)
Cohort 5A: TAK-114 20 mg
Orally, Twice daily, 10 days
干预措施: TAK-114 10 mg capsule (Drug)
Cohort 5B: TAK-114 20 mg
Orally, Twice daily, 10 days
干预措施: TAK-114 10 mg capsule (Drug)
Cohort 6A: TAK-114 50 mg
Orally, Twice daily, 10 days
干预措施: TAK-114 10 mg capsule (Drug)
Cohort 6B: TAK-114 50 mg
Orally, Twice daily, 10 days
干预措施: TAK-114 10 mg capsule (Drug)
Cohort 1A, 2A, 3A: TAK-114 placebo
Cohort 1A, 2A, 3A: Orally, once
干预措施: TAK-114 matched placebo (Drug)
Cohort 5A: TAK-114 placebo
Cohort 5A: Orally, Twice daily, 10 days
干预措施: TAK-114 matched placebo (Drug)
Cohort 6A: TAK-114 placebo
Cohort 6A: Orally, Twice daily, 10 days
干预措施: TAK-114 matched placebo (Drug)
结局指标
主要结局
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
时间窗: Baseline up to 3 days after the last dose of study drug (Day 3 in Part 1), (Day 20 in Part 2) and 7 days after the last dose of study drug (Day 17 in Part 3)
Number of Participants With TEAEs Related to Vital Signs
时间窗: Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3
Number of Participants With TEAEs Related to Body Weight
时间窗: Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3
Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)
时间窗: Baseline up to Day 2 (only for Cohorts 1A, 2A, and 3A) in Part 1
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis
时间窗: Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3
次要结局
- Cmax - Maximum Observed Plasma Concentration for TAK-114(Day1: predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day 1:predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2; Day 10:predose and at multiple time points (up to 12 hours) postdose for Part 3)
- AUC (0-Infinity) - Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Unchanged TAK-114: Part 1 and Part 2(Day 1: predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day 1: predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2)
- AUC (0-tau) - Area Under the Plasma Concentration-Time Curve From Time 0 to Time Tau for TAK-114: Part 3(Day10: predose and at multiple time points (up to 12 hours) postdose for Part 3)
- Mean Terminal Phase Elimination Half-life (T1/2) for TAK-114(Day1:predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day1:predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2; Day 10: predose and at multiple time points (up to 12 hours) postdose for Part 3)
- Mean R(Cmax): Mean Accumulation Coefficient of Observed Maximum Plasma Concentration for TAK-114: Part 3(Days 1 and 10: predose and at multiple time points (up to 12 hours) postdose for Part 3)
- Mean R(AUC): Mean of Accumulation Coefficient of Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-114: Part 3(Days 1 and 10: predose and at multiple time points (up to 12 hours) postdose for Part 3)
- Urinary Excretion Ratio of TAK-114 From 0 to 48 Hours Postdose: Part 1(Day 1: 0 to 48 hours postdose)