A Randomized, 9-Way, Single-Dose, Crossover Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of LY3185643 and rGlucagon in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3185643 and rGlucagon
研究概览
简要总结
The purpose of this study is to determine how the body handles LY3185643 and rGlucagon and what effects LY3185643 and rGlucagon have on the body. This study will also help to determine if LY3185643 is safe and well-tolerated.
This study will last at least 35 days, not including screening.
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
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are overtly healthy as determined by medical history and physical examination
- •Body mass index of 18.0 to 30.0 kilograms per square meter (kg/m²)
排除标准
- •Have participated, within the last 30 days, in a clinical trial involving an investigational product
- •Known allergies to LY3185643 or rGlucagon, related compounds, or any components of the formulation
- •History or electrocardiogram (ECG) evidence of heart block, or any abnormality in the 12-lead ECG
- •Abnormal blood pressure
- •History of recurring symptomatic postural hypotension irrespective of the decrease in blood pressure, or asymptomatic postural hypotension at screening as defined as a decrease in systolic blood pressure greater than or equal to (≥) 20 millimeter of Mercury (mm Hg) within 3 minutes when changing from supine to standing position
- •History of vasovagal response such as fainting
- •History of or current 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 investigational product; or of interfering with the interpretation of data
- •History of/current insulinoma and/or pheochromocytoma
- •Have used systemic glucocorticoids within 3 months before entry into the study
研究组 & 干预措施
LY3185643
LY3185643 administered subcutaneous (SC)
干预措施: LY3185643 (Drug)
rGlucagon
rGlucagon administered subcutaneous (SC)
干预措施: rGlucagon (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3185643 and rGlucagon
时间窗: 0 (pre-dose), 15, 30, 60, 120 and 180 minutes post-dose
Maximum observed plasma concentration (Cmax) was assessed for LY3185643 and rGlucagon.
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3185643 and rGlucagon
时间窗: 0 (pre-dose), 15, 30, 60, 120 and 180 minutes post-dose
Area under the concentration versus time curve from zero to infinity (AUC0-inf) was assessed for LY3185643 and rGlucagon.
Pharmacodynamics (PD): Change From Baseline in Maximum Concentration (Cmax) of Blood Glucose of LY3185643 and rGlucagon
时间窗: -5, 0 (pre-dose), 5, 10, 15, 22, 30, 45, 60, 75, 90, 105, 120, 150, 180 minutes post-dose
Cmax was assessed for LY3185643 and rGlucagon.
Pharmacodynamics (PD): Change From Baseline in Maximum Concentration (Cmax) of C-peptide of LY3185643 and rGlucagon
时间窗: -5, 0 (predose), 5, 15, 30, 60 and 120 minutes post-dose
Cmax was assessed for C-peptide of LY3185643 and rGlucagon
Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Time Curve (AUC) of Blood Glucose of LY3185643 and rGlucagon
时间窗: -5, 0 (pre-dose), 5, 10, 15, 22, 30, 45, 60, 75, 90, 105, 120, 150, 180 minutes post-dose
Area under the concentration versus time curve from time zero to 3 hours \[AUC (0-3)\] was assessed for LY3185643 and rGlucagon.
Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Time Curve (AUC) of C-Peptide of LY3185643 and rGlucagon
时间窗: -5, 0 (pre-dose), 5, 15, 30, 60 and 120 minutes post-dose
Area under the concentration versus time curve from time zero to 3 hours \[AUC (0-3)\] was assessed for C-peptide of LY3185643 and rGlucagon.
次要结局
未报告次要终点