NCT07247357已完成1 期
A Phase 1, Open-Label Study of the Pharmacokinetics of LY4064809 in Healthy Adult Chinese Participants
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4064809
研究概览
简要总结
The main purpose of this study is to measure how much LY4064809 gets into the bloodstream and how long it takes the body to eliminate it in healthy participants. It also looks at safety and tolerability in healthy participants. The study drug will be administered orally. The study will last approximately 21 days, excluding screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are native Chinese. To qualify as a native Chinese for the purpose of this study, all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China
- •Are overtly healthy as determined by medical evaluation, including medical history, physical examination, vital signs, and electrocardiogram (ECG) at screening and admission
- •Have clinical laboratory test results within the normal range for the population or investigative site, or with abnormalities deemed not clinically significant by the investigator at screening
- •Have a body mass index within the range 18 to 32 kilogram per square meter (kg/m²)
排除标准
- •History or presence of any of the following conditions, deemed clinically significant by the investigator (or designee), which may significantly alter the absorption, metabolism, or elimination of drugs, constitute a risk when taking the study intervention, or interfere with the data interpretation:
- •metabolic disease, including congenital non-hemolytic hyperbilirubinemia, for example, Gilbert syndrome
- •bile duct disease, including removal of the gall bladder
- •digestive system disease
- •blood disease
- •disease of the nervous system
- •significant history of, or presence of, liver disease, including any abnormal liver function tests, as defined by aspartate aminotransferase, alanine transaminase, or transducin beta-like above the 1.5× upper limit of normal range per the laboratory's reference ranges at screening, or
- •clinically significant, active cardiovascular disease or history of heart attack within 6 months prior to the planned start of LY4064809
- •Have a 12-lead ECG abnormality at screening or admission
- •History of a major surgical procedure within 30 days prior to screening
- •Diagnosed or treated cancer within 5 years prior to screening
- •Have known allergies to LY4064809 or related compounds
研究组 & 干预措施
LY4064809
Experimental
LY4064809 administered orally
干预措施: LY4064809 (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4064809
时间窗: Predose on Day 1 Through Day 14
PK: Cmax of LY4064809
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4064809
时间窗: Predose on Day 1 Through Day 14
PK: AUC of LY4064809
次要结局
未报告次要终点
研究者
研究点 (1)
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