A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of Single- and Multiple-Ascending Doses of LY3522348 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 65
- 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 LY3522348 and any side effects that might be associated with it. Blood tests will be performed to check how much LY3522348 gets into the bloodstream and how long it takes the body to eliminate it. This study has two parts: Part A will last up to about six weeks and Part B will last up to about eight weeks for each participant.
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 as determined through medical evaluation including medical history and physical examination
- •Have a body mass index of 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 one month prior to screening and enrollment (less than [<]5 percent [%] body weight change) and have not received dietary intervention in the one month prior to screening and enrollment
- •Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
排除标准
- •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 data analysis
- •Have blood pressure of 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
- •Have a history of fructosuria
- •Use of any drugs or substances that are known strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A) is specifically excluded within 14 days prior to the first administration of study intervention and during the study
研究组 & 干预措施
Part A: Placebo
A single dose of Placebo administered orally on Day 1.
干预措施: Placebo (Drug)
Part A: 5 milligrams (mg) LY3522348
A single dose of 5 mg LY3522348 administered orally on Day 1.
干预措施: LY3522348 (Drug)
Part A: 15 mg LY3522348
A single dose of 15 mg LY3522348 administered orally on Day 1.
干预措施: LY3522348 (Drug)
Part A: 50 mg LY3522348
A single dose of 50 mg LY3522348 administered orally on Day 1.
干预措施: LY3522348 (Drug)
Part A: 150 mg LY3522348
A single dose of 150 mg LY3522348 administered orally on Day 1.
干预措施: LY3522348 (Drug)
Part A: 380 mg LY3522348
A single dose of 380 mg LY3522348 administered orally on Day 1.
干预措施: LY3522348 (Drug)
Part B: Placebo
Placebo administered orally once daily on Days 1-14.
干预措施: Placebo (Drug)
Part B: Placebo + Midazolam
Placebo administered orally once daily on Days 1-15 and a single dose of 200 micrograms (μg) Midazolam administered orally on Days -1 and 15.
干预措施: Placebo (Drug)
Part B: Placebo + Midazolam
Placebo administered orally once daily on Days 1-15 and a single dose of 200 micrograms (μg) Midazolam administered orally on Days -1 and 15.
干预措施: Midazolam (Drug)
Part B: 50 mg LY3522348
50 mg LY3522348 administered orally once daily on Days 1-14.
干预措施: LY3522348 (Drug)
Part B: 120 mg LY3522348
120 mg LY3522348 administered orally once daily on Days 1-14.
干预措施: LY3522348 (Drug)
Part B: 290 mg LY3522348 + Midazolam
290 mg LY3522348 administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.
干预措施: LY3522348 (Drug)
Part B: 290 mg LY3522348 + Midazolam
290 mg LY3522348 administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.
干预措施: Midazolam (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: Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
An SAE is any untoward medical occurrence temporally associated with the use of study intervention that results in death is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation as determined by investigator. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported here. A summary of SAEs and other non-serious adverse events, regardless of causality, will be reported in the Reported Adverse Events module.
次要结局
- Part A Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC(0-tlast)) of LY3522348(Day 1 (Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144 hours post Day 1 dose))
- Part B PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC(0-tlast)) of LY3522348(Day 1 (Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16, 24 hours post Day 1 dose); Day 14 (Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 144 hours post Day 14 dose))
- Part A PK: Maximum Observed Drug Concentration (Cmax) of LY3522348(Day 1 (Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144 hours post Day 1 dose))
- Part B PK: Maximum Observed Drug Concentration (Cmax) of LY3522348(Day 1 (Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16, 24 hours post Day 1 dose); Day 14 (Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 144 hours post Day 14 dose))