Assessment of the Impact of Monomethoxy Polyethylene Glycols on the Pharmacokinetics and Glucodynamics of Single Doses of LY2605541 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Pharmacokinetics: Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY2605541
研究概览
简要总结
This study looks at the amount of LY2605541 in the body after it is injected under the skin. The study has 3 periods, each lasting 10 days. Each participant will receive one injection in each period. At least 14 days will pass between each injection.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are overtly healthy males or females, as determined by medical history and physical examination
- •A body mass index of 18.5 to 30 kilograms per meter square (kg/m^2)
排除标准
- •Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
- •Are women with a positive pregnancy test or are women who are lactating
- •Intend to use over-the-counter medication within 7 days prior to dosing or prescription medication within 14 days prior to dosing (apart from contraceptive medication, vitamin/mineral supplements, occasional acetaminophen, and/or hormone replacement therapy)
- •Have donated blood of more than 500 milliliters (mL) within the last month
- •Have an average weekly alcohol intake that exceeds 21 units per week (for males) and 14 units per week (for females)
- •Are excessive consumers of xanthines (more than 10 cups of tea, coffee, cola, or hot chocolate per day)
- •Have a fasting blood glucose (BG) >110 milligrams per deciliter (mg/dL) (6.1 millimoles per liter [mmol/L])
- •Currently smoke more than 10 cigarettes per day, or are unwilling to refrain from smoking for 72 hours prior to each dosing occasion and during confinement
研究组 & 干预措施
LY2605541 - Source 2
Each healthy participant will receive single SC injection of 0.5 U/kg of LY2605541 on Day 1 of 1of 3 treatment periods
干预措施: LY2605541 (Drug)
LY2605541 - Source 3
Each healthy participant will receive single SC injection of 0.5 U/kg of LY2605541 on Day 1 of 1 of 3 treatment periods
干预措施: LY2605541 (Drug)
LY2605541 - Source 1
Each healthy participant will receive a single subcutaneous (SC) injection of 0.5 units per kilogram (U/kg) of LY2605541 on Day 1 of 1 of 3 treatment periods
干预措施: LY2605541 (Drug)
结局指标
主要结局
Pharmacokinetics: Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY2605541
时间窗: Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post dose in each period
LY2605541 exposure in terms of AUC from time 0 extrapolated to infinity (AUC\[0-inf\]) is summarized for each PEG source (LY1, LY2, or LY3).
Pharmacokinetics: Maximum Concentration (Cmax) of LY2605541
时间窗: Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post dose in each period
The maximum observed drug concentration (Cmax) of LY2605541 is summarized for each PEG source (LY1, LY2, or LY3).
次要结局
- Glucodynamics: Maximum Glucose Infusion Rate (Rmax)(Predose and up to 24 hours post dose in each period)
- Glucodynamics: Total Amount of Glucose Infused (Gtot)(Predose and up to 24 hours post dose in each period)