Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Oral Doses of LY2922083 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
- 36
- 试验地点
- 1
- 主要终点
- Number of Participants With 1 or More Serious Adverse Event(s) (SAEs)
研究概览
简要总结
The aim of this trial is to evaluate the safety of the study drug in healthy participants and participants with diabetes. It will investigate 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 also be collected.
The study consists of two parts. Part A will study healthy participants in up to 3 dosing periods over approximately 6 weeks. Part B will study participants with diabetes in up to 3 dosing periods over approximately 6 weeks.
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
- Single (Participant)
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
- 否
入选标准
- •For all participants :
- •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 screening body mass index (BMI) of at least 18.0 kilograms per square meter (kg/m^2)
- •Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study
- •For participants with T2DM:
- •Do not have any change to their diabetes treatment (exercise with or without metformin) for at least 4 weeks prior to screening
- •Have a glycated hemoglobin (HbA1c) value of greater than or equal to 6% and less than or equal to 11% at screening
排除标准
- •For all participants :
- •Are currently participating in another clinical study or completed one in the last 30 days
- •Are allergic to LY2922083 or other related drugs
- •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 electrocardiogram (ECG) readings that are not suitable for the study
- •Have a history of hepatitis or jaundice
- •Are infected with hepatitis B
- •Are infected with hepatitis C
- •Are infected with human immunodeficiency virus (HIV)
- •Have donated more than 450 milliliters (mL) of blood in the last 3 months or have donated any blood in the last month
- •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)
- •Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic
- •For participants with T2DM :
- •Have had heart disease or stroke within 6 months before entering the study
- •Have health complications due to poorly controlled diabetes as shown by blood and urine laboratory test results or based on physical examination and medical assessment as determined by the study doctor
- •Have been hospitalized for poor control of diabetes (keto-acidotic episode) in the last 6 months
- •Have used insulin to control diabetes in the last 1 year
- •Show symptoms of high blood sugar (for example, frequent urination, always feeling thirsty, or unexpected weight loss)
研究组 & 干预措施
LY2922083 (Part B)
Single ascending dose of LY2922083 administered orally to participants with T2DM in up to 2 of 3 study periods in Part B. Dose determined by Part A
干预措施: LY2922083 (Drug)
Placebo (Part A)
Single oral dose of placebo administered to healthy participants in up to 1 of 3 study periods in Part A
干预措施: Placebo (Drug)
LY2922083 (Part A)
Single ascending dose of LY2922083 (starting at 0.5 milligrams [mg]) administered orally to healthy participants in up to 2 of 3 study periods in Part A
干预措施: LY2922083 (Drug)
Placebo (Part B)
Single oral dose of placebo administered to participants with type 2 diabetes mellitus (T2DM) in up to 1 of 3 study periods in Part B
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With 1 or More Serious Adverse Event(s) (SAEs)
时间窗: Baseline through study completion (up to 70 days)
Events deemed by the Investigator to be SAEs related to study drug administration are reported. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
次要结局
- Pharmacokinetics (PK): Area Under the Concentration Curve From Time 0 to Infinite Time [AUC(0-∞)] of LY2922083(Predose up to 72 hours (h) after each dose of study drug (Part A: predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose. Part B: predose, 0.5, 1.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose.))
- PK: Maximum Concentration (Cmax) of LY2922083(Predose up to 72 h after each dose of study drug (Part A: predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose. Part B: predose, 0.5, 1.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose.))
- Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time 0 to 6 h Postdose [AUEC(0-6)](Baseline (predose for Part A and Day -1 time-matched for Part B), up to 6 h postdose (1.5, 2.5, 4, 4.5, 5, and 6 h postdose))
- Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time 0 to 24 h Postdose [AUEC(0-24)](Baseline (predose for Part A and Day -1 time-matched for Part B), up to 24 h postdose (1.5, 2.5, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18, and 24 h postdose))