A Phase 1, 3-Part, Open-label, Drug-Drug Interaction Study to Evaluate the Effect of a Moderate CYP3A4 Inhibitor, and of Strong and Moderate CYP3A4 Inducers on the Pharmacokinetics of TAK-279 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Parts 1, 2, and 3: Cmax: Maximum Observed Plasma Concentration for 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 adult processes TAK-279 (pharmacokinetics) when substances that either hinder or help the human metabolism such as erythromycin, phenytoin and efavirenz are given along with TAK-279. Other aim is to learn about side effects and how well it is tolerated when TAK-279 is given alone and together with substances that impact human metabolism.
The participants will need to stay at the clinic for up to 26 days.
详细描述
The drug being tested in this study is called TAK-279. TAK-279 is being tested to assess the effect of a moderate CYP3A4 inhibitor (erythromycin- Part 1), and of strong (phenytoin- Part 2) and moderate (efavirenz- Part 3) CYP3A4 inducers on the pharmacokinetics of TAK-279 in healthy participants.
The study will enroll approximately 48 patients. Participants will be enrolled in one of the three parts to receive a single dose of TAK-279 in both Period 1 and Period 2 along with multiple doses of either erythromycin, phenytoin or efavirenz in Period 2 as given below:
- Part 1, Treatment A + Treatment B: TAK-279 50 mg + Erythromycin 500 mg
- Part 2, Treatment C + Treatment D: TAK-279 50 mg + Phenytoin 100 mg
- Part 3, Treatment E + Treatment F: TAK-279 50 mg + Efavirenz 600 mg
All participants will be monitored for up to 14 days postdose in each Part.
This single-center trial will be conducted in the United States. The overall study duration is approximately 65 days for Part 1, 73 days for Part 2, and 70 days for Part 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 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
Part 1, Treatment A + Treatment B: TAK-279 50 mg + Erythromycin 500 mg
Participants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg, on Day 5 and erythromycin 500 mg orally thrice daily (TID) on Day 1 through Day 10 of Period 2 in Part 1 of the study.
干预措施: TAK-279 (Drug)
Part 1, Treatment A + Treatment B: TAK-279 50 mg + Erythromycin 500 mg
Participants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg, on Day 5 and erythromycin 500 mg orally thrice daily (TID) on Day 1 through Day 10 of Period 2 in Part 1 of the study.
干预措施: Erythromycin (Drug)
Part 2, Treatment C + Treatment D: TAK-279 50 mg + Phenytoin 100 mg
Participants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg on Day 14 and phenytoin 100 mg orally TID on Day 1 through Day 18 of Period 2 in Part 2 of the study.
干预措施: TAK-279 (Drug)
Part 2, Treatment C + Treatment D: TAK-279 50 mg + Phenytoin 100 mg
Participants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg on Day 14 and phenytoin 100 mg orally TID on Day 1 through Day 18 of Period 2 in Part 2 of the study.
干预措施: Phenytoin (Drug)
Part 3, Treatment E + Treatment F: TAK-279 50 mg + Efavirenz 600 mg
Participants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg on Day 11 and efavirenz 600 mg orally once daily (QD) on Day 1 through Day 15 of Period 2 in Part 3 of the study.
干预措施: TAK-279 (Drug)
Part 3, Treatment E + Treatment F: TAK-279 50 mg + Efavirenz 600 mg
Participants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg on Day 11 and efavirenz 600 mg orally once daily (QD) on Day 1 through Day 15 of Period 2 in Part 3 of the study.
干预措施: Efavirenz (Drug)
结局指标
主要结局
Parts 1, 2, and 3: Cmax: Maximum Observed Plasma Concentration for TAK-279
时间窗: Predose and at multiple timepoints post dose from Day 1 period 1 (length= 6 days) to period 2 Day 11 in Part 1 (length= 11 days), up to period 2 Day 19 in Part 2 (length= 19 days) and up to period 2 Day 16 in Part 3 (length= 16 days)
Parts 1, 2, and 3: AUClast: Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration for TAK-279
时间窗: Predose and at multiple timepoints post dose from Day 1 period 1 (length= 6 days) to period 2 Day 11 in Part 1 (length= 11 days), up to period 2 Day 19 in Part 2 (length= 19 days) and up to period 2 Day 16 in Part 3 (length= 16 days)
Parts 1, 2, and 3: AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-279
时间窗: Predose and at multiple timepoints post dose from Day 1 period 1 (length= 6 days) to period 2 Day 11 in Part 1 (length= 11 days), up to period 2 Day 19 in Part 2 (length= 19 days) and up to period 2 Day 16 in Part 3 (length= 16 days)
次要结局
- Parts 1, 2, and 3: Number of Participants with Abnormal Laboratory Values(From Day 1 of period 1 through period 2 Day 11 (up to approximately 65 days) in Part 1, up to period 2 Day 19 (up to approximately 73 days) in Part 2 and up to period 2 Day 16 (up to approximately 70 days) in Part 3)
- Parts 1, 2, and 3: Number of Participants with Treatment-emergent Adverse Events (TEAEs)(From Day 1 of period 1 through period 2 Day 11 (up to approximately 65 days) in Part 1, up to period 2 Day 19 (up to approximately 73 days) in Part 2 and up to period 2 Day 16 (up to approximately 70 days) in Part 3)
- Parts 1, 2, and 3: Number of Participants with Abnormal Vital Signs(From Day 1 of period 1 through period 2 Day 11 (up to approximately 65 days) in Part 1, up to period 2 Day 19 (up to approximately 73 days) in Part 2 and up to period 2 Day 16 (up to approximately 70 days) in Part 3)
- Parts 1, 2, and 3: Number of Participants with Abnormal Electrocardiogram Findings(From Day 1 of period 1 through period 2 Day 11 (up to approximately 65 days) in Part 1, up to period 2 Day 19 (up to approximately 73 days) in Part 2 and up to period 2 Day 16 (up to approximately 70 days) in Part 3)