A Phase 1, Open-Label, Multiple-Dose Study to Investigate the Comparability of the Pharmacokinetics of Orforglipron (LY3502970) Single Capsule and Multiple Capsules in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 3
- 主要终点
- PK: Steady-state Maximum Concentration (Cmax) of Orforglipron (Fasted State)
研究概览
简要总结
The main purpose of this study is to assess and compare a single capsule and multiple capsules of Orforglipron 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 under fasted and fed conditions. How the body handles and eliminates the study drug after meals and on an empty stomach will be measured. Information about any adverse effects experienced will be collected and the safety and tolerability of Orforglipron will also be evaluated. The study will last approximately 21 weeks, including a 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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a stable body weight, that is, less than a 5% body weight change, for 1 month prior to randomization and body mass index (BMI) within the range 23.0 to 35.0 kilogram per square meter (kg/m²), inclusive
- •Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
- •Have venous access sufficient to allow for blood sampling
- •Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
排除标准
- •Have a hemoglobin A1c (HbA1c) test level greater than or equal to 6.5%
- •Have an estimated glomerular filtration rate less than 30 milliliter per minute per 1.73 square meter (mL/min/1.73m²)
- •Have a history of significant active or unstable major depressive disorder or other severe psychiatric disorder, for example, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder within the 2 years prior to screening
- •Actively suicidal and therefore deemed to be at significant risk for suicide
- •Have a known clinically significant gastric emptying abnormality
- •Have history or presence of acute or chronic pancreatitis or an elevation in serum lipase or amylase levels greater than 3 times the upper limit of normal (ULN)
- •Have an abnormal blood pressure (BP), pulse rate, or both
- •Have difficulty swallowing capsules
研究组 & 干预措施
Orforglipron
Participants will receive different sequences of Orforglipron doses administered as either single capsule or multiple capsules at different dose levels under either fasted or fed condition.
干预措施: Orforglipron (Drug)
结局指标
主要结局
PK: Steady-state Maximum Concentration (Cmax) of Orforglipron (Fasted State)
时间窗: Week 3 Through Week 16
PK: Steady-state Cmax of Orforglipron (Fasted State)
Pharmacokinetics (PK): Steady-state Area Under the Concentration Versus Time Curve (AUC) of Orforglipron (Fasted State)
时间窗: Week 3 Through Week 16
PK: Steady-state AUC of Orforglipron (Fasted State)
PK: Steady-state AUC of Orforglipron (Fed State)
时间窗: Week 3 Through Week 16
PK: Steady-state AUC of Orforglipron (Fed State)
PK: Steady-state Cmax of Orforglipron (Fed State)
时间窗: Week 3 Through Week 16
PK: Steady-state Cmax of Orforglipron (Fed State)
次要结局
未报告次要终点