A Study of Lasmiditan in Healthy Participants When Co-administered With Topiramate
2019年11月8日 更新者：Eli Lilly and Company
Safety, Tolerability, and Pharmacokinetics of Lasmiditan When Co-administered With Topiramate in Healthy Subjects
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.
研究概览
研究类型
介入性
注册 (实际的)
30
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Wisconsin
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Madison、Wisconsin、美国、53704
- Covance Madison CRU
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Lasmiditan Alone
Lasmiditan administered orally, alone
|
口服给药
其他名称：
|
|
安慰剂比较：Placebo Alone
Placebo administered orally, alone
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口服给药
|
|
实验性的：Topiramate + Lasmiditan
Topiramate administered orally, alone, and co-administered with oral lasmiditan
|
口服给药
其他名称：
Administered orally
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|
实验性的：Topiramate + Placebo
Topiramate administered orally, alone, and co-administered with oral placebo
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口服给药
Administered orally
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
大体时间：Baseline through Day 24
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A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
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Baseline through Day 24
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14
大体时间：Day 13 and Day 14: predose,0.5,1,1.5,2,3,4,6,8,12 hours(h)
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Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Topiramate when administered alone on Day 13 and when coadministered with lasmiditan on Day 14
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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
大体时间：Day 1 and Day 14: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours
|
PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14
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Day 1 and Day 14: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours
|
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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
大体时间：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 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
大体时间：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 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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年10月16日
初级完成 (实际的)
2017年12月2日
研究完成 (实际的)
2017年12月2日
研究注册日期
首次提交
2017年10月9日
首先提交符合 QC 标准的
2017年10月9日
首次发布 (实际的)
2017年10月12日
研究记录更新
最后更新发布 (实际的)
2019年11月27日
上次提交的符合 QC 标准的更新
2019年11月8日
最后验证
2018年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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