Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of LY3154207 in Healthy Subjects and Subjects With Parkinson's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 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 two-part study will evaluate how safe LY3154207 is and the effects it has on the body.
Part A will include healthy participants. Each participant will receive daily doses of LY3154207 or placebo for 14 days. Part A will last approximately 4 weeks including a 17 day stay in the clinical research unit (CRU) and follow-up.
Part B is contingent on the results of Part A. Part B will include participants with Parkinson's disease. Each participant will receive daily doses of LY3154207 or placebo for 14 days. Part B will last approximately 4 weeks including a 17 day stay in the CRU and follow-up.
Both Part A and Part B will require screening within 30 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overtly healthy males or females, as determined by medical history and physical examination
- •Female participants not of child-bearing potential
- •Have a clinical diagnosis of idiopathic Parkinson's disease for at least 1 year and on stable medication for at least 4 weeks
- •Part A and B
- •Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
- •Have given written informed consent
- •Have a body mass index (BMI) of 18.0 to 29.9 kilograms per square meter (kg/m²)
排除标准
- •Have participated, in the last 30 days, in a clinical trial involving an investigational product
- •Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; or constituting a risk when taking the study medication; or interfering with the interpretation of study data
研究组 & 干预措施
LY3154207
LY3154207 administered orally once daily in multiple-ascending dose cohorts for 14 days.
干预措施: LY3154207 (Drug)
Placebo
Placebo matching LY3154207 administered once daily for 14 days.
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 study completion (Day 15) in each part.
次要结局
- Plasma (blood) Pharmacokinetics: Maximum Concentration (Cmax) of LY3154207(At multiple time points from baseline through day 15 in each part)
- Plasma (blood) Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3154207 after a High-Calorie Meal(Baseline through 24 hours after administration of study drug on Day 10 in Part A.)
- Plasma (blood) Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3154207(At multiple time points from baseline through day 15 in each part)
- Plasma (blood) Pharmacokinetics: Maximum Concentration (Cmax) of LY3154207 after a High-Calorie Meal(Baseline through 24 hours after administration of study drug on Day 10 in Part A.)