A Multiple Dose Clinical Trial to Study the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of MK-8666 in Type 2 Diabetes Mellitus Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 63
- 主要终点
- Number of Participants Who Experienced at Least Once Adverse Event
研究概览
简要总结
This is a study of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-8666 in participants with type 2 diabetes mellitus (T2DM). Participants enrolled in this trial would be either treatment-naive or have washed off of oral anti-hyperglycemic agents. MK-8666 is planned to be administered orally for up to 2 weeks. The primary hypothesis for this study is that after 14 days of once daily treatment with MK-8666, at a dose that is safe and well tolerated, the placebo-corrected fasting plasma glucose reduction from baseline is ≥34 mg/dL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •If female, must be either postmenopausal or surgically sterile
- •A Body Mass Index (BMI) ≥18 kg/m^2 to ≤40 kg/m^2, inclusive.
- •A diagnosis of T2DM
- •Drug naïve or is being treated with no more than 2 oral antihyperglycemic agents (thiazolidenediones are excluded)
- •Judged to be in good health except for T2DM
- •Willing to follow a standard weight maintaining diet throughout the study
- •A nonsmoker or has not used nicotine or nicotine-containing products for at least 3 months
排除标准
- •A history of clinically significant endocrine (except T2DM), gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- •A history of myositis or complaints including diffuse myalgias, muscle tenderness, or weakness.
- •A history of cancer (malignancy) excepting adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix
- •Has clinically unstable diabetic retinopathy, neuropathy, and/or clinical evidence of gastroparesis (frequent nausea, bloating or vomiting, severe gastroesophageal reflux, early satiety)
- •A history of type 1 diabetes mellitus and/or history of ketoacidosis
- •Taking a medication for a co-morbid condition that is not permitted during the study
- •A history of significant multiple and/or severe allergies
- •Positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus
- •Had major surgery, donated or lost 1 unit of blood within 4 weeks prior to study participation
- •Participated in another investigational trial within 4 weeks prior to study participation
- •Consumes excessive amounts of alcoholic or caffeine-containing beverages
- •A regular user of illicit drugs or a history of drug or alcohol abuse within the past year
研究组 & 干预措施
MK-8666 50 mg
MK-8666, 50 mg, oral, once a day (QD) for Days 1 to 14.
干预措施: Placebo (Drug)
MK-8666 50 mg
MK-8666, 50 mg, oral, once a day (QD) for Days 1 to 14.
干预措施: MK-8666 (Drug)
MK-8666 150 mg
MK-8666, 150 mg, oral, QD, for Days 1 to 14
干预措施: MK-8666 (Drug)
MK-8666 150 mg
MK-8666, 150 mg, oral, QD, for Days 1 to 14
干预措施: Placebo (Drug)
MK-8666 500 mg
MK-8666, 500 mg, oral, QD for Days 1 to 14
干预措施: MK-8666 (Drug)
MK-8666 500 mg
MK-8666, 500 mg, oral, QD for Days 1 to 14
干预措施: Placebo (Drug)
Placebo
Placebo, oral, QD for Days 1 to 14
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Who Experienced at Least Once Adverse Event
时间窗: Up to 28 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 15
时间窗: Predose (Baseline) and 24 h postdose Day 14 (Day 15)
Blood glucose was measured on a fasting basis (collected after an 8-hour fast). Blood was collected on Day -1 (pre-planned dose), predose on Days 1, 3, 7, and 14, and 24h postdose Day 14 (Day 15). The baseline measurement was computed as the average of the Day -1 and predose Day 1 measurements. FPG is expressed as mg/dL. This change from baseline reflects values for Day 15 FPG minus Day 0 FPG values.
Number of Participants Who Discontinued Study Drug Due to an AE
时间窗: Up to 14 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
次要结局
- Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24h)(Day 1: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, and 24 hours postdose; Day 14 : Predose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours postdose)
- Maximum Plasma Drug Concentration After Dosing (Cmax)(Day 1: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, and 24 hours postdose; Day 14 : Predose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours postdose)
- Time to Reach Cmax (Tmax)(Day 1: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, and 24 hours postdose; Day 14 : Predose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours postdose)
- Change From Baseline in 24-Hour Weighted Mean Glucose (24h-WMG) at Day 15(Baseline and Day 15)