Safety, Tolerability, and Pharmacokinetics of Lasmiditan in Healthy Japanese and Caucasian Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
The main purpose of this study is to evaluate the safety and tolerability of lasmiditan in healthy Japanese and Caucasian participants. The study will also investigate how much lasmiditan gets into the bloodstream and how long it takes the body to get rid of lasmiditan when given to Japanese and Caucasians. The study will last up to 47 days for each participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are overtly healthy Japanese (first generation) or Caucasian males or females, as determined by medical history and physical examination
- •Have a body mass index of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive
排除标准
- •Have known allergies to lasmiditan, related compounds or any components of the formulation of lasmiditan
- •Have previously received the investigational product in this study, withdrawn from this study, or received lasmiditan in any other study investigating lasmiditan
- •Have an abnormal supine blood pressure at screening.
- •Have a history of syncope, presyncope, uncontrolled vertigo, postural dizziness, or a risk of falls, as judged to be clinically significant by the investigator, or have orthostatic decreases in supine blood pressure of >20 millimeters of mercury (mmHg), or have orthostatic decreases in diastolic blood pressure of >10 mmHg at screening.
- •Are women who are pregnant, lactating, or have a positive pregnancy test at screening or admission to the clinical research unit (CRU)
- •Have donated blood of more than 500 milliliters (mL) within 1 month prior to screening
研究组 & 干预措施
Lasmiditan - Japanese
Single (50 milligram (mg), 100 mg, 200 mg, 400 mg) and repeated (2 × 200 mg) doses of Lasmiditan administered orally in up to three of three study periods.
干预措施: Lasmiditan (Drug)
Placebo - Japanese
Single and repeated (2 X placebo) doses of Placebo administered orally in up to one of three study periods.
干预措施: Placebo (Drug)
Lasmiditan - Caucasian
Single (50 mg, 100 mg, 200 mg) dose of Lasmiditan administered orally in up to three of three study periods.
干预措施: Lasmiditan (Drug)
Placebo - Caucasian
Single dose of Placebo administered orally in up to one of three study periods.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline up to Day 20
The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. Summaries of SAEs and other non-serious adverse events (AEs), regardless of causality, are located in the Reported Adverse Events module.
次要结局
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan in Each Period(Period 1 and Period 2: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose; Period 3: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 36 and 48 hours postdose)
- PK: Maximum Observed Concentration (Cmax) of Lasmiditan in Each Period(Period 1 and Period 2: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose; Period 3: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 36 and 48 hours postdose)