A Randomized, Double-Blind, Placebo-Controlled, Ascending Oral Single Dose Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAK-418 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of TAK-418 following single oral doses in healthy participants.
详细描述
The drug being tested in this study is called TAK-418. TAK-418 is being tested in healthy participants in order to evaluate the safety, tolerability, and pharmacokinetics (PK) of single oral doses.
The study will enroll approximately 40 healthy participants. The study consists of equally divided 5 sequential cohorts of 8 participants each. In each of the following cohorts, 6 participants will be randomized to receive TAK-418 and 2 participants will receive matching placebo-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
- Cohort 1: TAK-418 5 mg
- Cohort 2: TAK-418 15 mg
- Cohort 3: TAK-418 30 mg Fasted + TAK-418 30 mg Fed
- Cohort 4: TAK-418 40 mg
- Cohort 5: TAK-418 60 mg
All participants will be asked to take TAK-418 or placebo-matching capsule once on Day 1 in each cohort. A washout period of 28-days will be maintained between the doses in Cohort 3.
This single center trial will be conducted in the United States. Participants in this study will be assigned to one of 5 possible dose cohorts. Male participants will return for additional outpatient visits on Days 91 and 93 (+/- 7 days) and may return for outpatient visits on Days 182 and 184 (+/- 7 days) (depending on results from the Day 93 Visit).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Is a male or female participants with a body mass index (BMI) within the range of 18.5 -30.0 kilogram per square meter (kg/m^2) at the Screening Visit.
- •Is a nonsmoker who has not used tobacco or nicotine-containing products (example, nicotine patch) for at least 6 months before trial drug administration of the initial dose of trial drug or invasive procedure.
- •Must be judged to be in good health by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead ECG, and vital sign measurements performed at the Screening Visit and before administration of the initial dose of trial drug or invasive procedure as per principal investigator's judgment.
- •Female subjects with no childbearing potential, defined by at least 1 of the following criteria:
- •Postmenopausal (defined as 12 months of spontaneous amenorrhea in women aged greater than [>]45 years, 6 months of spontaneous amenorrhea in women aged >45 years with serum follicle-stimulating hormone [FSH] levels >40 milli-international units per milliliter [mIU/mL]). Appropriate documentation of FSH levels is required.
- •Surgically sterile by hysterectomy and/or bilateral oophorectomy with appropriate documentation of surgical procedure.
- •Had a tubal ligation with appropriate documentation of surgical procedure.
- •Has a congenital condition resulting in no uterus.
排除标准
- •Has had major surgery, donated or lost 1 unit of blood (approximately 500 milliliter [mL]) within 4 weeks before the Screening Visit.
- •Has a risk of suicide according to the investigator's clinical judgment per the Columbia-Suicide Severity Rating Scale at Screening or has made a suicide attempt in the 6 months before Screening.
研究组 & 干预措施
Cohort 1: TAK-418 5 mg
TAK-418 5 milligram (mg), capsule, orally, once on Day 1.
干预措施: TAK-418 (Drug)
Cohort 2: TAK-418 15 mg
TAK-418 15 mg, capsule, orally, once on Day 1. Actual dose of TAK-418 may vary based on safety, tolerability and PK data from previous Cohorts.
干预措施: TAK-418 (Drug)
Cohort 3: TAK-418 30 mg Fasted + TAK-418 30 mg Fed
TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1, followed by a 28-day washout period, further followed by TAK-418 30 mg, capsule, in fed state, orally, once on Day 1. Actual dose of TAK-418 may vary based on safety, tolerability and PK data from previous Cohorts.
干预措施: TAK-418 (Drug)
Cohort 4: TAK-418 40 mg
TAK-418 40 mg, capsule, orally, once on Day 1. Actual dose of TAK-418 may vary based on safety, tolerability and PK data from previous Cohorts.
干预措施: TAK-418 (Drug)
Cohort 5: TAK-418 60 mg
TAK-418 60 mg, capsule, orally, once on Day 1. Actual dose of TAK-418 may vary based on safety, tolerability and PK data from previous Cohorts.
干预措施: TAK-418 (Drug)
Cohorts 1-5: Placebo
TAK-418 placebo-matching, capsule, orally, once on Day 1.
干预措施: TAK-418 Placebo (Drug)
结局指标
主要结局
Number of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
时间窗: Baseline Up to day 184
Number of Participants Who Meet the Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose
时间窗: Baseline Up to Day 14
Number of Participants Who Meet the Markedly Abnormal Criteria for Neurological Assessment Measurements at Least Once Post Dose
时间窗: Baseline Up to Day 184
Number of Participants Who Discontinued Due to an Adverse Event (AE)
时间窗: Baseline Up to Day 184
Number of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose
时间窗: Baseline Up to Day 184
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
时间窗: Baseline Up to Day 184
次要结局
- AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of TAK-418F (TAK-418 Free Base)(Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose)
- AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-418F(Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose)
- Cmax: Maximum Observed Plasma Concentration for TAK-418F(Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose)
- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-418F(Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose)