Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Oral Doses of LY3108743 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
- 44
- 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 tolerability of the study drug known as LY3108743 in healthy participants and in participants with type 2 diabetes.
The study will also investigate how LY3108743 affects the levels of blood sugar and other naturally occurring substances (e.g. hormones that control the way sugar is used) in the body, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it.
Information about any side effects that may occur will be collected. The study is expected to last approximately 7 to 8 weeks for each participant.
The study will have up to 3 parts. Participants may enroll in only one part.
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
- •Must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes
- •Have a body mass index (BMI) of 18.5 to 40.0 kilogram per square meter (kg/m^2), inclusive, at screening
- •Have normal blood pressure
- •Participants with diabetes must not be taking any anti-hyperglycemic medications with the exception of metformin. If on metformin, participants must be on a stable treatment regimen for at least for 4 weeks prior to screening
- •Participants with diabetes must have a hemoglobin A1c (HbA1c) level between 6 to 11%, inclusive, at screening
排除标准
- •Have previously completed or withdrawn from this study
- •Have or used to have health problems or laboratory test results or electrocardiogram (ECG) readings that, in the opinion of the doctor, could make it unsafe to participate or could interfere with understanding the results of the study
研究组 & 干预措施
Placebo - Healthy
Part A. Healthy participants will receive a single oral dose of placebo matching LY3108732 in at least 1 of 3 study periods.
干预措施: Placebo - Capsule (Drug)
LY3108743 - Healthy
Part A. Healthy participants will receive a single oral dose of LY3108743 in dose escalation cohorts in up to 2 of 3 study periods.
干预措施: LY3108743 - Capsule (Drug)
Placebo - Diabetes
Part B. Participants with diabetes mellitus will receive a single oral dose of placebo matching LY3108732 in at least 1 of 3 study periods.
干预措施: Placebo - Capsule (Drug)
LY3108743 - Diabetes
Part B. Participants with diabetes mellitus will receive a single oral dose of LY3108743 in dose escalation cohorts in up to 2 of 3 study periods.
干预措施: LY3108743 - Capsule (Drug)
Placebo - Solution
Part C. Contingent on results from Parts A and B. Healthy participants will receive a single oral dose of placebo matching LY3108743 in 1 of 2 study periods.
干预措施: Placebo - Solution (Drug)
LY3108743 - Solution
Part C. Contingent on results from Parts A and B. Healthy participants will receive a single oral dose of LY3108743 in 1 of 2 study periods.
干预措施: LY3108743 - Solution (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: Pre-dose up to Day 6 (5 days post-dose)
次要结局
- Maximum Change from Baseline up to 24 Hours in Level of Blood Glucose Before and After a Standard Meal(Baseline up to 24 hours)
- Pharmacokinetics: Maximum Concentration (Cmax) of LY3108743(Baseline up to 48 hours)
- Pharmacokinetics: Area Under the Curve (AUC) of LY3108743(Baseline up to 48 hours)