Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Oral Doses of LY2922470 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
- 26
- 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 aim of this trial is to evaluate the safety of the study drug in healthy participant and participant 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 4 dosing periods over approximately 6 weeks. Part B will study participants with diabetes in up to 3 dosing periods over approximately 5 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 Type 2 Diabetes Mellitus (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 LY2922470 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
- •Are infected with hepatitis B
- •Are infected with human immunodeficiency virus (HIV)
- •Have donated more than 450 milliliter (mL) of blood in the last 3 months or if 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 (e.g.), frequent urination, always feeling thirsty, or unexpected weight loss
研究组 & 干预措施
Placebo (Part A)
Single oral dose of placebo administered to healthy participants in up to 1 of 4 study periods in Part A
干预措施: Placebo (Drug)
LY2922470 (Part A)
Single ascending dose of LY2922470 [starting at 1 milligram (mg)] administered orally to healthy participants in up to 3 of 4 study periods in Part A
干预措施: LY2922470 (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)
LY2922470 (Part B)
Single ascending dose of LY2922470 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: LY2922470 (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: Baseline to study completion up to 33 days
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is located in the Reported Adverse Events module.
次要结局
- Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470(Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 48, 96 and 192 hours postdose)
- Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time Zero to 24 Hours [AUEC(0-24)](Baseline (predose for Part A and Day -1 time-matched for Part B), 24 hours postdose)
- Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time Zero to 6 Hours [AUEC(0-6)](Baseline (predose for Part A and Day -1 time-matched for Part B), 6 hours postdose)
- Pharmacokinetics: Area Under the Concentration Curve of LY2922470 From Time Zero to 24 Hours [AUC(0-24)](Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 48, 96 and 192 hours postdose)