A Single Dose Study to Assess the Pharmacokinetics of 2 Formulations of LY3819469 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3819469
研究概览
简要总结
The main purpose of this study is to assess two formulations of LY3819469 based on the amount that gets into the blood stream and how long it takes the body to get rid of it, when given to healthy participants. The information about any adverse effects experienced will be collected and the tolerability of LY3819469 will also be evaluated.
Screening is required within 28 days prior to the enrolment. For each participant, the total duration of the clinical trial will be about 17 weeks including screening and follow-up periods.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female participants who are overtly healthy as determined by medical evaluation
- •Have a body mass index (BMI) in the range of 18.5 to 35.0 kilogram per square meter (kg/m²), inclusive at the time of screening
- •Are male or women not of childbearing potential
排除标准
- •Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition that could affect interpretation of study data
- •Have any abnormality in the 12-lead electrocardiogram (ECG)
- •Are heavy alcohol drinkers or heavy cigarette smokers
- •Have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives, or 30 days, whichever is longer, should have passed prior to CRU admission
- •Have lost or donated blood of more than 450 mililitres (mL) within 3 months
研究组 & 干预措施
LY3819469 (Reference)
LY3819469 administered subcutaneously (SC).
干预措施: LY3819469 (Drug)
LY3819469 (Test)
LY3819469 administered SC.
干预措施: LY3819469 (Drug)
结局指标
主要结局
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3819469
时间窗: Predose on day 1 up to postdose on day 85
PK: AUC\[0-∞\] of LY3819469
PK: Maximum Observed Concentration (Cmax) of LY3819469
时间窗: Predose on day 1 up to postdose on day 85
PK: Cmax of LY3819469
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the Last Timepoint with Measurable Concentration (AUC[0-tlast]) of LY3819469
时间窗: Predose on day 1 up to postdose on day 85
PK: AUC\[0-tlast\] of LY3819469
次要结局
未报告次要终点