Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2409021 After Escalating Single Oral Dose Administration in Healthy Subjects and Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 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 main purpose of this study is to determine the safety of LY2409021 in healthy participants and participants with diabetes. The study drug is given as single oral doses. Each participant can receive up to 3 doses, with a minimum 7 day washout between dosing periods. Side effects will be documented. This study is approximately 9 weeks long, not including screening. Screening is required within 6 weeks prior to the start of the study.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For all participants:
- •Must be either a male, or a female who cannot become pregnant, who is either healthy or have type 2 diabetes mellitus (T2DM) but not taking medication for diabetes
- •Have an hemoglobin A1c (HbA1c) value of less than or equal to 10% at screening
- •Have blood and urine laboratory test results that are acceptable for the study
- •For healthy participants:
- •Have a screening body mass index (BMI) of 18.5 to 29.9 kg/m^2 inclusive
- •Have a fasting blood glucose between 3.0-5.2 millimoles/liter (mmol/L) at screening
- •Have plasma glucose, two hours after ingesting an oral 75 g glucose load, less than 7.8 mmol/L
- •For participants with type 2 diabetes mellitus (T2DM):
- •Have a screening body mass index (BMI) of 18.5 to 35 kg/m^2 inclusive
- •Must weigh 45 kg or more at screening
- •Have a fasting blood glucose less than 11.1 mmol/L at screening
- •Have plasma glucose, two hours after ingesting an oral 75 g glucose load, greater than or equal to 11.1 mmol/L
排除标准
- •For all participants:
- •Have participated in a study with a new drug in the last 30 days
- •Have a history of significant heart, lung, liver, kidney, stomach or brain disease, or have any medical problems which may cause an increased risk during the study
- •Have hypertension requiring more than single-agent therapy, or blood pressure greater than 140/90 millimeters of mercury (mmHg) on monotherapy
- •Are allergic to LY2409021 or similar drugs
- •Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female), or are unwilling to stop alcohol as required by the study restrictions (1 unit = 360 mL of beer, or 150 mL of wine, or 45 mL of spirits)
- •Intend to use other over-the-counter or prescribed medicines during 7 or 14 days respectively before the study, or during the study. Medicines for high cholesterol and high blood pressure are allowed if you have diabetes.
- •Have a significant blood disorder and/or donated blood (450 ml or more) in the last 3 months
- •For participants with T2DM:
- •Have signs of having serious problems with diabetes (For example, severe eye problems, poorly healing skin)
- •Have a history of being in a coma due to low blood sugar
研究组 & 干预措施
Healthy-30 mg LY2409021
30 mg LY2409021 administered once, orally
干预措施: LY2409021 (Drug)
Healthy-Placebo
Placebo (capsule) administered once, orally
干预措施: Placebo (Drug)
Healthy-2.5 mg LY2409021
2.5 mg LY2409021 administered once, orally
干预措施: LY2409021 (Drug)
Healthy-10 mg LY2409021
10 mg LY2409021 administered once, orally
干预措施: LY2409021 (Drug)
Healthy-100 mg LY2409021
100 mg LY2409021 administered once, orally
干预措施: LY2409021 (Drug)
Healthy-250 mg LY2409021
250 mg LY2409021 administered once, orally
干预措施: LY2409021 (Drug)
Healthy-500 mg LY2409021
500 mg LY2409021 administered once, orally
干预措施: LY2409021 (Drug)
Diabetic-Placebo
Placebo (capsule) administered once, orally
干预措施: Placebo (Drug)
Diabetic-75 mg LY2409021
75 mg LY2409021 administered once, orally
干预措施: LY2409021 (Drug)
Diabetic-200 mg LY2409021
200 mg LY2409021 administered once, orally
干预措施: LY2409021 (Drug)
Diabetic-500 mg LY2409021
500 mg LY2409021 administered once, orally
干预措施: LY2409021 (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: From first dose of study drug up to discharge (at least 14 days after last dose)
次要结局
- Pharmacokinetics: Area under the concentration curve (AUC) of LY2409021(From each dose of study drug up to 14 days post dose)
- Pharmacokinetics: Maximum concentration (Cmax) of LY2409021(From each dose of study drug up to 14 days post dose)
- Change in fasting blood glucose level(From each dose of study drug up to 48 hours post dose)
- Change in fasting insulin level(From each dose of study drug up to 48 hours post dose)
- Change in fasting glucagon level(From each dose of study drug up to 48 hours post dose)
- Change in fasting glucagon-like peptide-1 (GLP-1) level(From each dose of study drug up to 24 hours post dose)
- Glucose excursion after meals(28 hours after each dose)