A Phase 1, Single-Ascending-Dose, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3410738 in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 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 assess the safety and tolerability of LY3410738 and to look at the amount of the study drug, LY3410738, that gets into the blood stream and how long it takes the body to get rid of it when given in healthy adult participants. For each participant, the total duration of the study will be 53 days, including screening.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have Body mass index (BMI) within the range of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive
- •Male and female participants in good health, determined by no clinically significant findings from medical history, 12-lead Electrocardiogram (ECG), vital sign measurements, or clinical laboratory evaluations as assessed by the investigator
- •Female participants of non-childbearing potential and male participants who follow standard contraceptive methods
- •Must comply with all study procedures, including the 3-night stay at the Clinical Research Unit (CRU) and follow-up phone call
排除标准
- •History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor
- •Positive serologic test for hepatitis B surface antigen (HBsAg), hepatitis B virus immunoglobulin M (HBV IgM) core antibody, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody at Screening.
- •Positive polymerase chain reaction (PCR) test for COVID-19 at Screening
- •Known ongoing alcohol and/or drug abuse within 2 years prior to Screening
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee)
- •Have previously received LY3410738 in any other study investigating LY3410738, within 30 days prior to Day 1
研究组 & 干预措施
Cohort 7 (Treatment G): LY3410738
Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.
干预措施: LY3410738 (Drug)
Cohort 3 (Treatment C): LY3410738
Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.
干预措施: Placebo (Drug)
Cohort 1 (Treatment A): LY3410738
Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule formulation.
干预措施: LY3410738 (Drug)
Cohort 1 (Treatment A): LY3410738
Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule formulation.
干预措施: Placebo (Drug)
Cohort 2 (Treatment B): LY3410738
Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule formulation.
干预措施: LY3410738 (Drug)
Cohort 2 (Treatment B): LY3410738
Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule formulation.
干预措施: Placebo (Drug)
Cohort 3 (Treatment C): LY3410738
Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.
干预措施: LY3410738 (Drug)
Cohort 4 (Treatment D): LY3410738
Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.
干预措施: LY3410738 (Drug)
Cohort 4 (Treatment D): LY3410738
Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.
干预措施: Placebo (Drug)
Cohort 5 (Treatment E): LY3410738
Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.
干预措施: LY3410738 (Drug)
Cohort 5 (Treatment E): LY3410738
Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.
干预措施: Placebo (Drug)
Cohort 6 (Treatment F): LY3410738
Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.
干预措施: LY3410738 (Drug)
Cohort 6 (Treatment F): LY3410738
Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.
干预措施: Placebo (Drug)
Cohort 7 (Treatment G): LY3410738
Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.
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 53 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
- PK: Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of LY3410738(Pre-dose up to 48 hours post-dose)
- PK: Maximum Observed Plasma Concentration (Cmax) of LY3410738(Pre-dose up to 48 hours post-dose)
- PK: Time to Maximum Observed Plasma Concentration (Tmax) of LY3410738(Pre-dose up to 48 hours post-dose)
- Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to 24 Hours Post-dose (AUC0-24) of LY3410738(Pre-dose up to 24 hours post-dose)