Relative Bioavailability and Food Effect Study in Healthy Subjects Administered Two Different Formulations of LY3202626
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3202626
研究概览
简要总结
The purposes of this study are to determine:
- If there are any differences in the way LY3202626 is handled by the body when taken in two different forms
- Whether a high fat meal affects the way the body handles LY3202626
- How well tolerated LY3202626 is
There are three (3) study periods for all participants. Participants will be admitted to the clinical research unit (CRU) each period and will be discharged from the CRU following the completion of 2 overnight stays and up to 36 hours after dosing with LY3202626.
The study will last about 50 days, not 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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are overtly healthy males or females, as determined by medical history and physical examination
- •Female participants must be of non-childbearing potential confirmed by medical history or menopause
- •Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m²) inclusive, at screening
排除标准
- •Are investigative site personnel directly affiliated with this study and their immediate families
- •Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
- •Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed
- •Have previously completed or withdrawn from this study or any other study investigating LY3202626, and have previously received the investigational product
- •Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
- •Have a history of head trauma with loss of consciousness within the last 5 years
- •Have known or ongoing psychiatric disorders
研究组 & 干预措施
LY3202626 (R-Fasting)
Single oral dose of LY3202626 (R) capsule under fasting conditions.
干预措施: LY3202626 (R-Fasting) (Drug)
LY3202626 (T1-Fasting)
Single oral dose of LY3202626 (T1) tablet under fasting conditions.
干预措施: LY3202626 (T1-Fasting) (Drug)
LY3202626 (T1-Fed)
Single oral dose of LY3202626 (T1) following a high fat breakfast.
干预措施: LY3202626 (T1-Fed) (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3202626
时间窗: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose
Pharmacokinetics (PK) is the maximum observed drug concentration (Cmax) of LY3202626
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3202626
时间窗: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose
PK is the area under the concentration versus time curve from time zero to infinity (AUC\[0-∞\]) of LY3202626
PK: AUC From Time Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3202626
时间窗: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose
PK is the AUC from time zero to time t, where t is the last time point with a measurable concentration (AUC\[0-tlast\]) of LY3202626
次要结局
未报告次要终点