A Multiple Dose Study in Healthy Participants to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3502970
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 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 assess how fast LY3502970 gets into the blood stream and how long it takes the body to remove it when administered in multiple oral doses as new formulation compared to that of reference LY3502970 formulation. Information about safety and tolerability will be collected. The study is open to healthy participants. The study is conducted in two parts and it will last up to about 6 months, inclusive of 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
- Single (Participant)
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 overtly healthy as determined by medical evaluation.
- •Body mass index (BMI) of 18.5 to 35 kilograms per meter squared (kg/m²).
排除标准
- •Have an abnormal blood pressure and/or pulse rate as determined by the investigator -minor deviations acceptable to investigator are allowed
- •Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) greater than 2X ULN (Upper Limit of Normal)
- •Have an abnormality in the 12-lead ECG at screening that, in the opinion of the investigator, increases the risks associated with participating in the study
- •Are women of child-bearing potential
- •Are women who are lactating
结局指标
主要结局
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970
时间窗: Predose up to 24 hours postdose
PK: Cmax of LY3502970
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3502970
时间窗: Predose up to 24 hours postdose
PK: AUC of LY3502970
PK: Time of Maximum Observed Concentration (Tmax) of LY3502970
时间窗: Predose up to 24 hours postdose
PK: Tmax of LY3502970
次要结局
未报告次要终点