A Single Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY3006072 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs
研究概览
简要总结
The purpose of this study is to evaluate how safe LY3006072 (study drug) is and whether it causes any side effects. The study will also measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of the study drug. The study drug will be given in the morning or evening with or without a meal.
This is the first time that this study drug is being given to humans. This study is for research purposes only and is not intended to treat any medical condition.
详细描述
This study has two parts:
Part A - single ascending dose of LY3006072 administered to healthy participants in 3 of 4 study periods (placebo in 1 of 4 periods).
Part B - morning and evening doses of LY3006072 given to healthy participants in fed and fasted states in 2 or 3 of 3 study periods (placebo in 1 of 3 periods for some participants).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overtly healthy males or females, as determined by medical history and physical examination
- •Male participants with a partner of childbearing potential must agree to use barrier protection during sexual intercourse while in the study and for 3 months after the last dose of study drug
- •Women must not be pregnant or nursing and must be of non-childbearing potential, due to either surgical sterilization or menopause
- •Body mass index between 19.0 and 30.0 kilograms per square meter (kg/m^2), inclusive
排除标准
- 未提供
研究组 & 干预措施
Placebo
Participants received placebo capsule orally with approximately 200 to 300 milliliter (mL) of room temperature water in the morning.
干预措施: Placebo (Drug)
LY3006072
Participants received LY3006072 capsules starting at 1 milligram (mg) and escalating doses of 3 mg, 10 mg, 20 mg and 40 mg.
干预措施: LY3006072 (Drug)
结局指标
主要结局
Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs
时间窗: Baseline, up to 21 days
AEs that were considered possibly related to study drug, in the opinion of the investigator, were reported. A summary of serious and all other non-serious AEs, regardless of possible drug relatedness, is located in the Reported Adverse Event module.
次要结局
- Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3006072(Predose, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 96 hours postdose)
- Pharmacokinetics: Maximum Concentration (Cmax) of LY3006072(Predose, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 96 hours postdose)