A Phase 1, Open-Label, Single-Dose Pharmacokinetic Study of Lasmiditan in Pediatric Patients With Migraine
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 10
- 主要终点
- PK: Area Under the Concentration-Versus-Time Curve (AUC) From Time Zero to Infinity (AUC[0-∞]) of Lasmiditan
研究概览
简要总结
The purpose of the study is the measure the levels of lasmiditan in the body of children aged 6 to 17 with migraine. The study also will also examine the safety and tolerability of lasmiditan in children aged 6 to 17 with migraine.
The study will last about 6 weeks, and includes 4 visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have a history of migraine headaches for more than 6 months
- •Participants must have a history of 2 to 15 migraine headaches per month in the past 2 months
- •Participants must weigh between 15 and 55 kilograms (kg)
- •Participants must not have a migraine headache on the day of lasmiditan administration
排除标准
- •Participants must not be pregnant or nursing
- •Participants must not have any acute, serious, or unstable medical condition
- •Participants must not be actively suicidal or at significant risk for suicide, in the opinion of the investigator
- •Participants must not be on a medicine that acts in the brain and spinal cord
研究组 & 干预措施
Lasmiditan
Participants with lower body weight (15 to ≤40 kilograms (kg)) received single oral dose of 100 milligrams (mg) Lasmiditan in Cohort 1 and higher body weight (>40 to ≤55 kg) participants received single oral dose of 200 mg Lasmiditan in Cohort 2.
干预措施: Lasmiditan (Drug)
结局指标
主要结局
PK: Area Under the Concentration-Versus-Time Curve (AUC) From Time Zero to Infinity (AUC[0-∞]) of Lasmiditan
时间窗: 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose
PK: Area Under the Concentration-Versus-Time Curve (AUC) from Time Zero to Infinity (AUC\[0-∞\]) of Lasmiditan.
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan
时间窗: 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan.
次要结局
未报告次要终点