A Randomized Double-Blind Placebo-Controlled Single and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8655 in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 主要终点
- Fasting Plasma Glucose (FPG)
研究概览
简要总结
This study will assess the initial safety, tolerability, pharmacokinetics, and pharmacodynamics of MK-8655, after single and multiple daily oral administrations to participants with Type 2 Diabetes (T2DM). The study will assess the reduction in fasting plasma glucose concentrations from baseline after multiple daily administrations of MK-8655.
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
- •Male or female of non-child bearing potential
- •Body Mass Index ≤40 kg/m^2
- •Diagnosis of Type 2 Diabetes (T2DM) and is either drug naive or is being treated with metformin only
- •In good health except for T2DM
- •Willing to follow a standard diet
- •Nonsmoker and/or no use of nicotine or nicotine-containing products for 6 months
排除标准
- •Mentally or legally incapacitated
- •History of stroke, chronic seizures, or major neurological disorder
- •History of clinically significant endocrine (except T2DM), gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- •History of neoplastic or myeloproliferative diseases
- •Has clinical unstable or rapidly progressing diabetic retinopathy, neuropathy, and/or frequent nausea, bloating or vomiting, severe gastroesophageal reflux or early satiety
- •Has a history of Type 1 Diabetes and/or history of ketoacidosis
- •Use of any lipid-lowering therapies in the past 3 months
- •Non-permitted medication for a co-morbid condition
- •Excessive alcohol or caffeine use
- •Participation in another investigational study within 4 weeks prior to this study
- •A history of significant multiple and/or severe allergies or anaphylactic reactions
- •Regular user of any illicit drugs or history of alcohol abuse within 6 months
研究组 & 干预措施
MK-8655 80 mg/MK-8655 320 mg
Participants received a single dose of MK-8655, 80 mg on Day 1 and then MK-8655 320 mg, once daily, starting on Day 3 for 14 consecutive days.
干预措施: MK-8655 (Drug)
Placebo
Participants received a single dose of placebo to MK-8655, 80 mg on Day 1 and then placebo to MK-8655 320 mg, once daily, starting on Day 3 for 14 consecutive days.
干预措施: Placebo (Drug)
结局指标
主要结局
Fasting Plasma Glucose (FPG)
时间窗: Day 16 (Predose)
Blood for fasting plasma glucose (central laboratory) was obtained after at least 10 hours overnight fast.
Number of Participants With One or More Adverse Events
时间窗: Up to 14 days after the last dose of study drug (Up to 31 days)
An adverse event 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.
Number of Participants Discontinuing Study Drug Due to an Adverse Event
时间窗: Up to 17 days
An adverse event 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
- True Geometric Mean Plasma Concentrations of MK-8655 After Single and Multiple Drug Doses at 24 Hours Post Dose (C24)(24 hours post dose on Days 1, 7, and 14)
- Change From Baseline at 2 Hours Oral Glucose Tolerance Test(Baseline and 2 hours after dosing on Days 1, 3, and 16)
- 24-Hour Weighted Mean Glucose (WMG)(Day 15: Predose, 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 18, 21, 23 hours post-dose.)