Safety, Tolerability, and Pharmacokinetics of Lasmiditan When Co-administered With Topiramate in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 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
This study will assess the safety, tolerability and blood concentrations of lasmiditan and topiramate together compared to lasmiditan and topiramate separately. Information about any side effects that may occur will be collected.
Participants will be admitted to the Clinical Research Unit (CRU) one day prior to the start of the study and will remain through Day 14.
This study is expected to last approximately 25 days, not including screening. Screening is required within 28 days prior to the start of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are healthy males or females (of non-child bearing potential), as determined by medical history and physical examination
- •Have a body mass index of 19.0 to 35.0 kilograms per meter squared (kg/m²) inclusive
排除标准
- •Have known allergies to lasmiditan, topiramate, related compounds or any components of the formulation of lasmiditan or topiramate
- •Have an abnormal supine blood pressure, defined as systolic blood pressure less than (<) 90 or great (>) 140 millimeters of mercury (mmHg) or diastolic blood pressure <60 or >90 mmHg at screening
- •Have known or ongoing psychiatric disorders considered clinically significant by the investigator or demonstrate suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS)
- •Have a clinically significant abnormality in the neurological examination
- •Have current or a history of orthostatic hypotension (>20-mmHg drop in systolic blood pressure, or >10-mmHg drop in diastolic blood pressure) with or without dizziness and/or syncope at screening or admission to the Clinical Research Unit (CRU) upon repeat testing
- •Have an estimated glomerular filtration rate using Modification of Diet in Renal Disease <60 milliliter per minute (mL/min) per 1.73 meter squared (m²)
- •Have a history of glaucoma
- •Have a history of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
研究组 & 干预措施
Topiramate + Placebo
Topiramate administered orally, alone, and co-administered with oral placebo
干预措施: Topiramate (Drug)
Lasmiditan Alone
Lasmiditan administered orally, alone
干预措施: Lasmiditan (Drug)
Placebo Alone
Placebo administered orally, alone
干预措施: Placebo (Drug)
Topiramate + Lasmiditan
Topiramate administered orally, alone, and co-administered with oral lasmiditan
干预措施: Lasmiditan (Drug)
Topiramate + Lasmiditan
Topiramate administered orally, alone, and co-administered with oral lasmiditan
干预措施: Topiramate (Drug)
Topiramate + Placebo
Topiramate administered orally, alone, and co-administered with oral placebo
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 through Day 24
A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
次要结局
- Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14(Day 13 and Day 14: predose,0.5,1,1.5,2,3,4,6,8,12 hours(h))
- PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14(Day 1 and Day 14: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours)
- PK: Area Under the Plasma Concentration Versus Time Curve During One Dosing Interval (AUC [Tau]) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14(Day 13 and Day 14 - predose,0.5,1,1.5,2,3,4,6,8,12 hours(h))
- PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity AUC(0-∞) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14(Day 1 and Day 14: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours)