A Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3873862 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
The main purpose of this study is to evaluate the safety and tolerability of LY3873862 when administered either in single or multiple doses in healthy participants. The study will also assess how fast LY3873862 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to approximately 58, 72, and 72 days for Part A, B, and C, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Participants who are overtly healthy as determined by medical evaluation
- •Body mass index (BMI) within the range 18.0 to 32.0 kilograms per meter squared (kg/m²)
- •Are male or female participants, including those of childbearing potential
排除标准
- •Have a history or presence of medical illness including, but not limited to, any cardiovascular, renal, hepatic, gastrointestinal, respiratory, hematologic, endocrine, psychiatric, or neurological disease, convulsions, or any clinically significant laboratory abnormality that, in the judgment of the investigator, indicate a medical problem that would preclude study participation.
- •Are unwilling to comply with the dietary restrictions required for this study, including the avoidance by 5 days prior to study drug administration until the final ambulatory visit the ingestion of fruits, sauces, and juices containing furanocoumarins that irreversibly inhibit cytochrome P450 (CYP)3A
- •The following fruits, sauces, and juices are excluded: grapefruit, Seville oranges, pomelos, cranberry, Goji berry, and apple.
研究组 & 干预措施
LY3873862 (Part A)
LY3873862 administered orally as single dose.
干预措施: LY3873862 (Drug)
Placebo (Part A)
Placebo administered orally.
干预措施: Placebo (Drug)
LY3873862 (Part B)
LY3873862 administered orally as multiple doses.
干预措施: LY3873862 (Drug)
Placebo (Part B)
Placebo administered orally.
干预措施: Placebo (Drug)
LY3873862 (Part C)
LY3873862 administered orally as multiple doses.
干预措施: LY3873862 (Drug)
Placebo (Part C)
Placebo administered orally.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline through 72 days
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3873862(Predose up to 96 hours postdose)
- PK: Area Under the Concentration versus Time Curve at Steady State (AUCτ) of LY3873862(Predose up to 96 hours postdose)
- PK: Maximum Observed Concentration (Cmax) of LY3873862(Predose up to 96 hours postdose)
- PK: Time of Maximum observed Concentration (Tmax) of LY3873862(Predose up to 96 hours postdose)