A Single-Dose, Dose Escalation, Safety, Tolerability, and Pharmacokinetic Study of LY3050258
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 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 is to evaluate the safety and how well the body will handle a single dose of increasing strength of study drug LY3050258. Each participant will receive LY3050258 or placebo once, in each of 2 dosing periods. At least 7 days will pass between doses. This study will last approximately 45 days for each participant. Screening is required within 28 days before the start of the study.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or healthy postmenopausal females, including Japanese participants
- •Have a body mass index (BMI) of 18 to 35 kilograms per square meter (kg/m^2)
排除标准
- •An abnormal sitting blood pressure as determined by the investigator
- •Any abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, places the participant at an unacceptable risk for study participation
- •Current use of statins within the last 3 months prior to dosing
- •Current or previous use of anabolic steroids in the preceding 6 months prior to dosing
- •Use of dehydroepiandrosterone, other potential over-the-counter (OTC) steroidal supplements, or other nutritional products intended to have weight-reduction and/or performance-enhancing effects within 21 days prior to dosing
研究组 & 干预措施
LY3050258
Single escalating dose of LY3050258 (2 milligram [mg] up to 200 mg) administered in up to two of two periods.
干预措施: LY3050258 (Drug)
Placebo
Single dose of placebo matching LY3050258 administered in up to one of two periods.
干预措施: Placebo (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 21 days postdose
Data presented are the number of participants who experienced SAEs which were considered to be related to study treatment by the investigator while on treatment and during the follow-up. Summaries of SAEs and other non-serious adverse events (AEs), regardless of causality, are located in the Reported Adverse Events module.
次要结局
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3050258(Period 1: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours (h) postdose and Day 7 postdose; Period 2: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 h postdose and Days 7, 14, and 21 postdose.)
- PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY3050258(Period 1: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 h postdose and Day 7 postdose; Period 2: predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 h postdose and Days 7, 14, and 21 postdose)