A Single Dose Pharmacokinetic Study of LY2409021 in Healthy Subjects to Bridge Formulations From Capsules to Commercial Tablets
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2409021
研究概览
简要总结
The purpose of this study is to measure how much of the new LY2409021 tablet formulations get into the blood stream and how long it takes the body to get rid of them, compared to the current LY2409021 capsule formulation. In addition, the safety and tolerability of both the new and current formulations will be evaluated. Information about any side effects that may occur will also be collected. The study has two parts. Each participant may enroll in one part only. The study will last up to 8 weeks for each participant. Screening is required prior to the start of the study.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overtly healthy males or surgically sterile or postmenopausal females, as determined by medical history and physical examination
- •Have a body mass index (BMI) of 18.0 to 32.0 kilogram per square meter (kg/m^2)
- •Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
排除标准
- •Have known allergies to LY2409021, related compounds or any components of the formulation, or history of significant atopy
- •Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
- •Have known or ongoing psychiatric disorders
研究组 & 干预措施
Part A: LY2409021 Tablet Commercial
Single oral dose of LY2409021 tablet (commercial formulation) in one of three study periods.
干预措施: LY2409021 (Drug)
Part A: LY2409021 Capsule
Single oral dose of LY2409021 capsule in one of three study periods.
干预措施: LY2409021 (Drug)
Part A: LY2409021 Tablet Pre-commercial
Single oral dose of LY2409021 tablet (pre-commercial formulation) in one of three study periods.
干预措施: LY2409021 (Drug)
Part B: LY2409021 Capsule
Single oral dose of LY2409021 capsule in one of two study periods.
干预措施: LY2409021 (Drug)
Part B: LY2409021 Tablet Commercial
Single oral dose of LY2409021 tablet (commercial formulation) in one of two study periods.
干预措施: LY2409021 (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2409021
时间窗: Day 1: Predose, 0.5 Hours (H), 1 H, 4 H, 8 H, 12 H, 24 H, 48 H, 72 H, 96 H, 144 H, 192 H, 264 H, 336 H Postdose in Each Period
PK: Maximum Plasma Concentration (Cmax) of LY2409021
时间窗: Day 1: Predose, 0.5 H, 1 H, 4 H, 8 H, 12 H, 24 H, 48 H, 72 H, 96 H, 144 H, 192 H, 264 H, 336 H Postdose in Each Period
次要结局
未报告次要终点