A Phase I, Participant- and Investigator-Blind, Single-center Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of LY3871801 in Healthy Asian and Non-Asian Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
The main purpose of this study is to evaluate the safety and tolerability of LY3871801 when administered as multiple doses in Healthy Asian and Non-Asian Participants. The study will also evaluate the amount of LY3871801 that gets into the blood stream and how long it takes the body to get rid of it in these participants. The study will be conducted in two parts (A & B). The study will last up to approximately 24 days excluding the screening period.
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 Japanese, Chinese, or Non-Asian participants who are overtly healthy as determined by medical evaluation
- •Have body weight of >/= 45 kilograms (kg) & a body mass index (BMI) in the range of 18.5 to 29.5 kilogram per square meter (kg/m²). The Japanese participants must have a body weight of 45 to 85 kg and a BMI of 18.0 to 29.5 kg/m²
排除标准
- •Have known allergies to LY3871801, related compounds, or any components of the formulation, or history of significant atopy
- •Have a significant history of or current cardiovascular or heart failure (based on New York Heart Association Functional Classification), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
- •Are females who are lactating or have a positive pregnancy test at screening or Day 1
- •Positive for drug or alcohol screen at screening or Day -1
- •Smoke more than 10 cigarettes per day
研究组 & 干预措施
LY3871801 (Part A)
LY3871801 administered orally in Japanese and Non-Asian Participants.
干预措施: LY3871801 (Drug)
Placebo (Part A)
Placebo administered orally in Japanese and Non-Asian Participants.
干预措施: Placebo (Drug)
LY3871801 (Part B)
LY3871801 administered orally in Chinese Participants.
干预措施: LY3871801 (Drug)
Placebo (Part B)
Placebo administered orally in Chinese Participants.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Predose up to 24 days post dose
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3871801(Predose on Day 1 up to postdose on Day 17)
- PK: Area Under the Concentration Versus Time Curve (AUC) of LY3871801(Predose on Day 1 up to postdose on Day 17)