A Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, 3-Part Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAK-951 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
Feeling sick in the stomach (nausea) or throwing up (vomiting) are among the most common symptoms during treatment with medicines. It is hoped that a medicine called TAK-951 may help people to not feel sick in the stomach or throw up. The main aim of this study is to learn about side effects of TAK-951 when given as a single or multiple doses to healthy adults. Side effects are medical problems thought to be caused by the study treatment. Another aim is to learn how a healthy adult's body processes TAK-951 (this is called pharmacokinetics or PK). In this study, participants will receive either TAK-951 or placebo. The placebo looks like TAK-951 but does not have any medicine in it. Both TAK-951 and placebo will be given as an injection directly under the skin. This is called subcutaneous or subcutaneous (SC).
The study will be conducted in 3 parts:
- In Part 1, participants will be given one SC injection of either TAK-951 or placebo.
- In Part 2, participants will receive up to three daily SC injections of either TAK-951 or placebo of the same dose
- In Part 3, participants will receive one SC injection of either TAK-951 or placebo and another SC injection up to 1 week later.
Participants will be checked for their health either 28 days after the last injection (Parts 1 and 2) or 14 days after the last injection (Part 3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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, Cohort 4: TAK-951 Dose 4
Participants will receive a single SC dose of TAK-951 Dose 4 on Day 1.
干预措施: TAK-951 (Drug)
Part 1, Cohort 5: TAK-951 Dose 5
Participants will receive a single SC dose of TAK-951 Dose 5 on Day 1.
干预措施: TAK-951 (Drug)
Part 1, Cohort 6: TAK-951 Dose 6
Participants will receive a single SC dose of TAK-951 Dose 6 on Day 1.
干预措施: TAK-951 (Drug)
Part 2: TAK-951 Multiple Rising Doses
Participants will receive multiple rising SC doses of TAK-951 twice daily (BID) or 3 times a day (TID) in Part 2.
干预措施: TAK-951 (Drug)
Part 3: TAK-951 Multiple Dose Titration
Participants will receive multiple rising SC doses of TAK-951 once daily (QD), BID, or TID from Days 1 to 5 followed by a washout period of 2 to 7 days and a single redose on any day from Days 8 to 13 in Part 3.
干预措施: TAK-951 (Drug)
Part 1: Pooled Placebo
Participants will receive a single SC dose of TAK-951 matching placebo on Day 1.
干预措施: Placebo (Drug)
Part 1, Cohort 1: TAK-951 Dose 1
Participants will receive a single SC dose of TAK-951 Dose 1 on Day 1.
干预措施: TAK-951 (Drug)
Part 1, Cohort 2: TAK-951 Dose 2
Participants will receive a single SC dose of TAK-951 Dose 2 on Day 1.
干预措施: TAK-951 (Drug)
Part 1, Cohort 3: TAK-951 Dose 3
Participants will receive a single SC dose of TAK-951 Dose 3 on Day 1.
干预措施: TAK-951 (Drug)
结局指标
主要结局
Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
时间窗: From the first dose of study drug up to Day 29 in Part 1
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug. An AE can be any unfavorable and unintended sign (including physical examinations, vital signs, electrocardiogram (ECG), laboratory assessment findings), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. A TEAE was defined as an AE that started or worsened after first study drug administration and within 30 days of last dose of study drug.
Part 2: Number of Participants With TEAEs
时间窗: From the first dose of study drug up to Day 33 in Part 2
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug. An AE can be any unfavorable and unintended sign (including physical examinations, vital signs, ECG, laboratory assessment findings), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. A TEAE was defined as an AE that started or worsened after first study drug administration and within 30 days of last dose of study drug.
Part 3: Number of Participants With TEAEs
时间窗: From the first dose of study drug up to Day 27 in Part 3
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug. An AE can be any unfavorable and unintended sign (including physical examinations, vital signs, ECG, laboratory assessment findings), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. A TEAE was defined as an AE that started or worsened after first study drug administration and within 30 days of last dose of study drug.
次要结局
- Part 2: Maximum Observed Plasma Concentration (Cmax) for TAK-951 on Day 1 of Drug Dosing(Predose and at multiple time points post-dose up to 24 hours on Day 1 in Part 2)
- Part 2: Time of First Occurrence of Cmax (Tmax) for TAK-951 on Day 1 of Drug Dosing(Predose and at multiple time points post-dose up to 24 hours on Day 1 in Part 2)
- Part 2: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC24) for TAK-951 on Day 1 of Drug Dosing(Predose and at multiple time points post-dose up to 24 hours on Day 1 in Part 2)
- Part 2: AUCτ: Area Under the Plasma Concentration-time Curve During a Dosing Interval for TAK-951 on Day 1(Predose and at multiple time points post-dose up to 24 hours on Day 1 in Part 2)
- Part 2: AUCτ for TAK-951 at Steady State(Predose and at multiple time points post-dose up to 24 hours on Day 1 in Part 2)
- Part 2: AUC24 for TAK-951 at Steady State(Predose on Day 1 and at multiple time points post-dose up to 24 hours on Day 1 in Part 2)
- Part 2: Cmax,ss: Maximum Observed Concentration at Steady State for TAK-951(Predose on Day 1 and at multiple time points post-dose up to Day 7 in Part 2)
- Part 2: Tmax for TAK-951 at Steady State(Predose on Day 1 and at multiple time points post-dose up to Day 7 in Part 2)
- Part 2: Terminal Disposition Phase Half-life (t1/2z) for TAK-951 at Steady State(Predose on Day 1 and at multiple time points post-dose up to Day 7 in Part 2)
- Part 2: Apparent Clearance After Extravascular Administration (CL/F) for TAK-951 at Steady State(Predose on Day 1 and at multiple time points post-dose up to Day 7 in Part 2)
- Part 2: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration (Vz/F) for TAK-951 at Steady State(Predose on Day 1 and at multiple time points post-dose up to Day 7 in Part 2)
- Part 2: Ctrough: Observed Plasma Concentration at the End of a Dosing Interval for TAK-951 at Steady State(Predose on Day 1 and at multiple time points post-dose up to Day 7 in Part 2)
- Part 2: Rac[AUC]: Accumulation Ratio Based on AUCτ for TAK-951 at Steady State(Predose on Day 1 and at multiple time points post-dose up to Day 7 in Part 2)
- Part 2: Rac[Cmax]: Accumulation Ratio Based on Cmax for TAK-951 at Steady State(Predose on Day 1 and at multiple time points post-dose up to Day 7 in Part 2)
- Part 3: Number of Participants With AEs(From the re-treatment dose of study drug (any day from Days 8 to 13) up to Day 27 in Part 3)
- Part 1: Number of Participants Based on Antidrug Antibodies (ADA) Status in Serum(Predose on Day 1 and post-dose on Days 14 and 29 in Part 1)
- Part 2: Number of Participants With ADA(Predose on Day 1 and post-dose on Days 14 and 29 in Part 2)
- Part 3: Number of Participants With ADA(Predose on Day 1 and post-dose on Days 14 and 29 in Part 3)