A 2-Part, Safety, Tolerability, and Pharmacokinetic Study of LY2775240 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
This study is conducted to determine the side effects related to LY2775240 given orally to healthy participants. Blood tests will be done to check how much LY2775240 is absorbed into the bloodstream and how long the body takes to get rid of it. Each participant will enroll in either Part A or Part B of the study, which will last about 14 weeks and 8 weeks respectively, including screening.
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
- 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
- •Overtly healthy adult male or a female who cannot get pregnant
- •Have a screening body mass index (BMI) of greater than 18 and less than or equal to 32 kilograms per meter square (kg/m²), inclusive
- •Have normal blood pressure, pulse rate, electrocardiogram (ECG) and medical test results that are acceptable for the study
排除标准
- •Are currently participating in or completed a clinical trial within the last 30 days from a clinical trial or any other type of medical research judged to be incompatible with this study
- •Have known allergies to compounds or drugs similar to LY2775240 or apremilast
- •Have previously participated or withdrawn from this study
- •Have or used to have health problems or medical test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
研究组 & 干预措施
LY2775240 (Part A)
Escalating oral doses of LY2775240 administered in healthy participants
干预措施: LY2775240 (Drug)
LY2775240 (Part B)
Oral dose of LY2775240 in healthy participants
干预措施: LY2775240 (Drug)
Placebo (Part A)
Placebo administered orally in healthy participants
干预措施: Placebo (Drug)
Apremilast (Part B)
Oral dose of apremilast in healthy participants
干预措施: Apremilast (Drug)
结局指标
主要结局
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline through to final follow-up at approximately Week 14
次要结局
- Pharmacokinetics: Time to Maximal Blood Concentration of LY2775240(Baseline through Day 5)
- Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2775240(Baseline through Day 5)
- Pharmacokinetics: Maximum Concentration of LY2775240 in Blood(Baseline through Day 5)