Relative Bioavailability and the Effect of Food on the Bioavailability of LY3337641 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3337641
研究概览
简要总结
The purposes of this study are to determine:
- If there are any differences in the amount of LY3337641 in the blood/body when it is taken in different formulations. A total of 3 different formulations of LY3337641 are being tested.
- How a high-fat meal affects the amount of LY3337641 in the blood/body.
- How safe and well tolerated LY3337641 is.
The study has four periods. Individuals will participate in all four periods. Each period will include 4 overnight stays (5 days) in the Clinical Research Unit (CRU).
This study is expected to last up to 8 weeks. This includes the initial screening period, the study or dosing period, and the follow up 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
- 21 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 males or females, as determined by medical history and physical examination
- •Have a body mass index (BMI) of 18.5 to 32 kilograms per meter squared (kg/m²) inclusive
- •Have clinical laboratory test results within normal reference range for the population or investigative site
- •Are able and willing to give signed informed consent
排除标准
- •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 significant history of or current cardiovascular, dermatological (such as eczema, psoriasis, and acne), respiratory, hepatic, renal, gastrointestinal (cholecystectomy is not acceptable), 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 used or intend to use over-the-counter or prescription medication, including herbal medications, within 14 days prior to planned dosing
- •In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study
研究组 & 干预措施
LY3337641 (R-fasted)
A single, PO dose of reference formulation (R) given orally with water after an overnight fast in one of four periods.
干预措施: Reference Formulation (R) (Drug)
LY3337641 (T1-fasted)
A single, PO dose of LY3337641(20mg) test formulation 1 (T1) given orally with water after an overnight fast in one of four periods.
干预措施: LY3337641 (T1) (Drug)
LY3337641 (T1-fed)
A single, PO dose of LY3337641 (20mg) test formulation 1 (T1) given orally with water after a high fat meal in one of four periods.
干预措施: LY3337641 (T1) (Drug)
LY3337641 (T2-fasted)
A single, PO dose of LY3337641 (20 mg) test formulation 2 (T2) given orally with water after an overnight fast in one of four periods.
干预措施: LY3337641 (T2) (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3337641
时间窗: Period 1,2,3,4 (Day 1): Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48 and 72 hours postdose
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC\[0-∞\]) of LY3337641
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3337641
时间窗: Period 1,2,3,4 (Day 1): Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48 and 72 hours postdose
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3337641
次要结局
未报告次要终点