A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of Single-and Multiple Ascending Doses of LY3478045in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Number of Participants With One or More 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 in healthy participants is to learn more about the safety of LY3478045 and any side effects that might be associated with it. The study will also measure how much LY3478045 gets into the bloodstream and how long it takes the body to get rid of it.
This study has two parts: Part A (one dose) will last about six weeks and Part B (more than one dose) will last about eight weeks for each participant.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are overtly healthy participants as determined through medical history and physical examination
- •Have a body mass index greater than or equal to (≥)18.5 and less than or equal to (≤)40 kilograms per square meter (kg/m²)
- •Have had a stable weight for 3 months prior to screening and enrollment (less than [<]5 percent [%] body weight change) and have not received dietary intervention in the 3 months prior to screening and enrollment
- •Have safety laboratory test results within the normal reference range for the population or investigative site, or results with acceptable deviations that are judged as not clinically significant by the investigator
排除标准
- •Have a history of fructosuria
- •Have an abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG (QT) data analysis
- •Have blood pressure greater than (>)160/90 millimeters of mercury (mmHg) and pulse rate <50 or >100 beats per minute (bpm), supine (at screening), or with minor deviations judged to be acceptable by the investigator
- •Use of any drugs or substances that are known strong inducers or inhibitors of cytochrome P450 (CYP)3A or organic anion-transporting polypeptides (OATPs) are specifically excluded within 14 days prior to the first administration of study drug and during the study
研究组 & 干预措施
LY3478045 (Part B)
Participants received multiple ascending oral dose of 60mg and 300 mg LY3478045 once-daily (QD)for 14 days.
干预措施: LY3478045 (Drug)
Placebo (Part B)
Participants received oral dose of placebo QD for 14 days.
干预措施: Placebo (Drug)
LY3478045 (Part A)
Participants received single ascending oral dose of 20 milligram (mg), 60mg, 180 mg, 500 mg, 700 mg LY3478045 on Day 1.
干预措施: LY3478045 (Drug)
Placebo (Part A)
Participants received single oral dose of placebo on Day 1.
干预措施: Placebo (Drug)
LY3478045 + Atorvastatin (Part B)
Participants received multiple ascending oral doses of 160 mg, 360 mg LY3478045 QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
干预措施: LY3478045 (Drug)
LY3478045 + Atorvastatin (Part B)
Participants received multiple ascending oral doses of 160 mg, 360 mg LY3478045 QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
干预措施: Atorvastatin (Drug)
Placebo + Atorvastatin (Part B)
Participants received oral dose of placebo QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
干预措施: Placebo (Drug)
Placebo + Atorvastatin (Part B)
Participants received oral dose of placebo QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
干预措施: Atorvastatin (Drug)
结局指标
主要结局
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 Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is reported in the Reported Adverse Events module.
次要结局
- PK: Maximum Concentration (Cmax) of LY3478045(Part A: Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 95 hours post dose; Part B: Day 1: Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16 and 24 hours post dose; Day 14: Predose ,0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post dose)
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3478045(Part A: Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 95 hours post dose; Part B: Day 1: Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16 and 24 hours post dose; Day 14: Predose ,0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post dose)