Effect of Age on the Pharmacokinetics, Safety, and Tolerability of Lasmiditan in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan
研究概览
简要总结
The purpose of this study is to look at the amount of study drug that gets into the blood stream and how long it takes the body to get rid of it by comparing the results of healthy elderly participants to those of healthy young participants. The tolerability of the study drug will be evaluated. Information about any side effects that may occur will also be collected.
This study will last up to approximately 19 days, not including screening. This study requires either one (Group 2) or two (Group 1) stays at the clinic each of at least four days/three nights. Participants will return for a follow-up seven days after last dose of study drug. Screening is required within 28 days prior to Day 1.
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
- 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are overtly healthy males or females, as determined by medical history and physical examination.
- •Have a body mass index (BMI) of 19 to 35 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.
- •Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study.
- •Show evidence of active renal disease or estimated glomerular filtration rate (eGFR) less than 60 milliliter per minute (mL/min) per 1.73 m².
- •Show evidence of or positive serology for human immunodeficiency virus (HIV) infection, hepatitis B or C.
- •Are women with a positive pregnancy test or women who are lactating.
- •Have a clinically significant abnormality in the neurological examination.
- •Have a history of syncope, presyncopy, uncontrolled vertigo, postural dizziness, or at risk for falls, as judged to be clinically significant by the investigator.
- •Have orthostatic hypotension with or without dizziness and/or syncope at screening or Day -1 upon repeat testing, or a history of it.
研究组 & 干预措施
200 mg Lasmiditan (Group 1 Elderly)
200 milligrams (mg) lasmiditan on Day 1 of 1 of 2 dosing periods.
干预措施: Lasmiditan (Drug)
Placebo (Group 1 Elderly)
Placebo on Day 1 of 1 of 2 dosing periods.
干预措施: Placebo (Drug)
200 mg Lasmiditan (Group 2 Young)
200 mg lasmiditan on Day 1.
干预措施: Lasmiditan (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan
时间窗: Day 1:Predose,0.5, 1, 1.5,2, 2.5, 3, 4,6, 8, 12 hours; Day 2: 24,36 hours; Day 3:48 hours
Maximum Observed Drug Concentration (Cmax) of Lasmiditan.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan
时间窗: Day 1:Predose,0.5, 1, 1.5,2, 2.5, 3, 4,6, 8, 12 hours; Day 2: 24,36 hours; Day 3:48 hours
Area under the concentration versus time curve from zero to infinity
次要结局
未报告次要终点