An Open-Label, Two-Period Study to Evaluate the Pharmacokinetics of Lasmiditan in Migraineurs During Acute Migraine Attacks and During Inter-Ictal Periods
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 3
- 主要终点
- Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan in Each Period
研究概览
简要总结
The purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it during an acute migraine attack and also during the time between acute migraine attacks.
Information about any side effects that may occur will also be collected.
This study includes two study periods. Each study period requires an overnight stay in the Clinical Research Unit (CRU) for at least one night (and up to three nights), followed by up to two outpatient appointments. This study will last approximately 5-6 weeks (not including screening).
Follow-up is required four to seven days after last dose of investigational drug. Screening is required within 28 days prior to the start of the study.
This study is for research purposes only and is not intended to treat any medical condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females with history of migraine with or without aura, as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1 and 1.2) (ICHD-3 beta, Cephalalgia 2013), for at least 1 year, based on medical history
- •Have a body mass index (BMI) of 18.0 to 40.0 kilograms per meter squared (kg/m²) inclusive, at the time of screening
排除标准
- •Have known allergies to lasmiditan, related compounds, or any components of the formulation of lasmiditan
- •Have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed
- •Have an abnormal blood pressure, defined as systolic blood pressure less than or equal to (≤) 90 or greater than (>) 155 millimeters of mercury (mmHg) or diastolic blood pressure ≤ to 50 or >95 mmHg
- •Have clinically significant electrocardiogram (ECG) findings, including a QT interval corrected for heart rate using QT interval corrected for heart rate using Fridericia's formula (QTcF) value >450 milliseconds (ms) (males) or >470 ms (females), clinically significant bradycardia, cardiac block, or bradyarrhythmias
- •Have a history of, show evidence of, or are undergoing treatment for significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, major depressive disorder)
- •Have a history of gastrointestinal surgery, or a history of or current irritable bowel syndrome, mal-absorptive disorders, or other gastrointestinal motility disorders. Appendectomy, splenectomy, and cholecystectomy are considered as acceptable
- •Have used or intend to use any migraine prevention treatments (including, but not limited to, propranolol or topiramate) within 30 days prior to dosing and until the follow-up visit
研究组 & 干预措施
Lasmiditan (Period 1)
200 mg Lasmiditan tablet given once orally during migraine attack.
干预措施: Lasmiditan (Drug)
Lasmiditan (Period 2)
200 mg Lasmiditan tablet given once orally during inter-ictal period.
干预措施: Lasmiditan (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan in Each Period
时间窗: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8,12, 18, 24, 48, and 72h post-dose
PK: Cmax of Lasmiditan in Each Period.
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan in Each Period
时间窗: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8,12, 18, 24, 48, and 72h post-dose
PK: AUC(0-∞) of Lasmiditan in Each Period.
次要结局
- PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period(Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, and 72h post-dose)
- PK: Maximum Observed Drug Concentration (Cmax) of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period(Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, and 72h post-dose)