A Safety, Tolerability and Pharmacokinetic Study of Single and Multiple Doses of LY3526318 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Part A - SAD, Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞) of LY3526318
研究概览
简要总结
The main purpose of this study is to learn more about how the drug is absorbed in to the blood stream and how it is eliminated from the body. The safety and tolerability of LY3526318 will also be evaluated when given by mouth either by single or multiple doses to healthy participants. The study will have two parts. Each participant will enroll in only one part. For each participant, Part A will last up to 44 days and Part B will last up to 50 days, including screening and follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •Are overtly healthy males or females, as determined through medical history and physical examination
- •Have a body mass index (BMI) between 18 and 32 kilograms per square meter (kg/m²)
- •Have clinical laboratory test results within normal reference range
排除标准
- •Have a history or presence of medical illness including, but not limited to, cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, convulsions, or any clinically significant laboratory abnormality
- •Have an abnormality in the 12-lead electrocardiogram (ECG)
- •Have a history of clinically significant multiple or severe drug allergies
- •Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies, hepatitis C and/or positive hepatitis C antibody, or hepatitis B and/or positive hepatitis B surface antigen.
- •Have an abnormal blood pressure
- •Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer)
- •Are unwilling to stop herbal supplements, over the counter or prescription medicines
- •Are currently enrolled in a clinical drug study or any other type of medical research judged not to be scientifically or medically compatible with this study.
- •Participants with a history of drug abuse
研究组 & 干预措施
LY3526318 (Part A)
250 mg, 100 milligram (mg) LY3526318 administered orally as single ascending doses under fasted or fed condition.
干预措施: LY3526318 (Drug)
LY3526318 (Part B)
250 mg LY3526318 administered orally as multiple doses under fasted or fed condition.
干预措施: LY3526318 (Drug)
Placebo (Part A)
Placebo administered orally under fasted or fed condition.
干预措施: Placebo (Drug)
Placebo (Part B)
Placebo administered orally under fasted or fed condition.
干预措施: Placebo (Drug)
结局指标
主要结局
Part A - SAD, Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞) of LY3526318
时间窗: Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose
Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞) of LY3526318
Part A - SAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
时间窗: Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose
Part A - SAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
Part B - MAD, PK: Area Under the Concentration Time Curve From Time Zero to the End of the Dosing Interval, Tau (AUC[0-tau ]) of LY3526318
时间窗: Day 5: Predose,1, 2, 4, 6, 8,12, 24 hours post dose
Part B - MAD, PK: Area Under the Concentration Time Curve From Time Zero to the End of the Dosing Interval, Tau (AUC\[0-tau \]) of LY3526318
Part B - MAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
时间窗: Day 5: Predose,1, 2, 4, 6, 8,12, 24 hours post dose
Part B - MAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
次要结局
- Part A, SAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Single oral dose to up to 11 days of follow-up)
- Part B, MAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Up to 14 days following first dose)
- Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Maximum Concentration (Cmax)(Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose)
- Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞)(Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose)
- Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Time at Maximal Concentration (Tmax)(Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose)