A Multiple Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-1403 in Participants With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 10
- 主要终点
- Number of participants who experience one or more adverse events (AE)
研究概览
简要总结
The purpose of this study is to learn about the safety and if people tolerate a study medicine called MK-1403. The study will also measure what happens to MK-1403 in the body of a person with type 2 diabetes (T2D) over time (pharmacokinetic or PK study), and how it affects the amount of high-sensitivity C-reactive protein (hsCRP) in a person's blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a confirmed diagnosis of Type 2 diabetes mellitus (T2DM)
- •Has body mass index (BMI) between 18 and 40 kg/m^2, inclusive
排除标准
- •Has Type 1 diabetes mellitus or secondary types of diabetes
- •Has a history of congestive heart failure (New York Heart Association [NYHA] Class 3 or 4)
- •Has history of myocardial infarction, uncontrolled arrhythmias, cardiac revascularization, angina, unstable peripheral arterial disease and/or stroke
- •Has history of cancer (malignancy)
- •Has positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or human immunodeficiency virus (HIV)
- •Has a history of gastrointestinal (GI) disease which might affect food and drug absorption, or has had gastric bypass or similar surgery
研究组 & 干预措施
Panel A MK-1403 + additive coformulation dose 1
Participants will receive MK-1403 + additive coformulation dose 1 orally once daily.
干预措施: MK-1403 + additive coformulation (Drug)
Panel A Placebo + additive coformulation dose 1
Participants will receive Placebo + additive coformulation dose 1 orally once daily.
干预措施: Placebo + additive coformulation (Drug)
Panel B MK-1403 + additive coformulation dose 2
Participants will receive MK-1403 + additive coformulation dose 2 orally once daily
干预措施: MK-1403 + additive coformulation (Drug)
Panel B Placebo + additive coformulation dose 2
Participants will receive Placebo + additive coformulation dose 2 orally once daily
干预措施: Placebo + additive coformulation (Drug)
结局指标
主要结局
Number of participants who experience one or more adverse events (AE)
时间窗: Up to approximately 28 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience one or more AEs will be reported.
Number of participants who discontinue study intervention due to adverse events
时间窗: Up to approximately 14 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported.
次要结局
- Change from Baseline in Placebo-Corrected High Sensitivity C-Reactive Protein (hsCRP) Serum Concentration(Baseline and 24-hours postdose on Day 14)
- Plasma concentration of MK-1403 at 24 Hours Postdose (C24) on Day 14(24-hour postdose on Day 14)