A Single- and Multiple-Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of LY3867070 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 196
- 试验地点
- 4
- 主要终点
- Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
The purpose of this study is to evaluate how well LY3867070 is tolerated and what side effects may occur in healthy participants. The study drug will be administered orally. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.
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)
盲法说明
Part D will be open-label
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 as determined by medical evaluation
- •Part C of the study includes only Japanese and Chinese participants
- •Have a body weight greater than or equal to 45 kilogram (kg) and also body mass index 18 to 32 kilogram per square meter (kg/m²) inclusive
排除标准
- •Have a history or presence of multiple or severe allergies, anaphylactic reaction to prescription or nonprescription drugs, or history of significant atopy
- •Have a significant history or current thyroid disease
- •Have a significant history of or current psychiatric disorders, rheumatologic, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (such as Cushing syndrome and hyperaldosteronism), hematological, or neurological disorders
- •Are smokers (including electronic cigarettes) within 6 months prior to screening and unwilling to refrain from smoking for the duration of the study.
- •Unwilling to undergo skin biopsies (for Part B only)
- •Are unwilling to have body hair cut or shaved in cases where hair, in the investigator's opinion, could interfere with noninvasive skin patch
研究组 & 干预措施
LY3867070 (Part A)
Single-Ascending Dose of LY3867070 administered orally
干预措施: LY3867070 (Drug)
LY3867070 (Part B)
Multiple-Ascending Doses of LY3867070 administered orally
干预措施: LY3867070 (Drug)
LY3867070 (Part C)
Multiple Doses of LY3867070 administered orally
干预措施: LY3867070 (Drug)
Placebo (Parts A-C)
Placebo administered orally
干预措施: Placebo (Drug)
LY3867070 (Part D)
Drug-Drug Interaction (DDI) administered orally
干预措施: LY3867070 (Drug)
结局指标
主要结局
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline up to Approximately Week 7
A summary of TEAEs regardless of causality, will be reported in the Reported Adverse Events module
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline up to Approximately Week 7
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
Number of Participants with One or More Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline up to Approximately Week 7
A summary of 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 (AUC) of LY3867070(Baseline up to Approximately Week 7)
- PK: Maximum Concentration (Cmax) of LY3867070(Baseline up to Approximately Week 7)
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3867070(Baseline up to Approximately Week 7)
- PK: Maximum Concentration (Cmax) of LY3867070(Baseline up to Approximately Week 7)
- Part B Pharmacodynamic (PD): Change from Baseline in Gene Expression(Baseline up to Approximately Week 6)