A Phase 1 Multiple Dose Study to Investigate the Pharmacokinetics, Safety, and Tolerability of LY3502970 in Fed and Fasted Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970
研究概览
简要总结
The main purpose of this study is to conduct blood tests to measure how much LY3502970 is in the bloodstream and how the body handles and eliminates LY3502970 in healthy participants in fed and fasted states. The study will also evaluate the safety and tolerability of LY3502970 in these participants. The study will last up to 49 days excluding the screening period.
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
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are overtly healthy as determined by medical evaluation.
- •Participants with body weight of 45 kilograms (kg) or more and body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m²).
排除标准
- •Participants who have an abnormal blood pressure and/or pulse rate, deemed to be clinically significant by the investigator at screening.
- •Participants who used or intend to use over-the-counter (OTC) or prescription medication and/or herbal/vitamin/traditional medicines or mineral supplements that may affect the safety or objectives of the study, within 14 days prior to dosing and for the duration of the study. Paracetamol and Covid-19 vaccinations are permitted.
- •Participants who are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study.
- •Participants who show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies. A negative test within 6 months of screening would not need to be repeated.
- •Participants who show evidence of hepatitis C and/or positive hepatitis C antibody. A negative test within 6 months of screening would not need to be repeated.
- •Participants who show evidence of hepatitis B, positive hepatitis B surface antigen, and/or positive hepatitis B core antibody. A negative test within 6 months of screening would not need to be repeated.
结局指标
主要结局
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970
时间窗: Predose up to 41 days postdose
PK: Cmax of LY3502970
PK: Time to Maximum Observed Concentration (Tmax) of LY3502970
时间窗: Predose up to 41 days postdose
PK: Tmax of LY3502970
PK: Area Under the Concentration-time curve from 0 to 24 hour (AUC0-24) of LY3502970
时间窗: Predose up to 41 days postdose
PK: AUC0-24 of LY3502970
次要结局
未报告次要终点