A Multiple Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-1006.
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 112
- 主要终点
- Number of Participants Experiencing Adverse Events (AEs) On Study
研究概览
简要总结
This study will asses the safety, tolerability, multiple-dose pharmacokinetics and pharmacodynamics of MK1006 in participants with type 2 diabetes.
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
- •Participant has a BMI less than or equal to 42 kg/m^2 at the screening visit
- •Participant has been diagnosed with Type 2 Diabetes that is being treated either by diet and exercise alone or by single or combination oral anti-hyperglycemic medications
- •Participant is willing to follow a diet containing approximately 50% carbohydrates, 20% protein, and 30% fat during the study
- •Participant is a nonsmoker and has not used nicotine containing products for ~ 6 months before start of study
排除标准
- •Participant must not be treated with three or more oral anti-hyperglycemic medications, insulin, or PPAR-gamma agonists
- •Participant has a history of stroke, chronic seizures, or a major neurological disorder
- •Participant has had an eye infection or other inflammatory eye condition within 2 weeks of first dose of study drug
- •Participant has glaucoma or is blind
- •Participant has a condition known to be related to cataract development
- •Participant has had or will have incisional eye surgery within 6 months before screening or has had laser surgery (other than Lasik) within 3 months of screening
- •Participant has a history of type 1 diabetes or ketoacidosis
- •Participant cannot stop taking certain current medications during the study
- •Participant consumes greater than 3 alcoholic beverages per day
- •Participant consumes more than 6 servings of caffeinated beverages per day (1 serving is ~ 120 mg caffeine)
- •Participant has a history of significant multiple or severe allergies or has had a reaction to or is intolerant of prescription/non-prescription drugs or food
- •Participant uses recreational drugs or has had a history of drug abuse within 6 months of start of study
研究组 & 干预措施
MK-1006 20 mg Once Daily (Panel A)
After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
干预措施: MK-1006 (Drug)
MK-1006 40 mg Once Daily (Panel B)
After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
干预措施: MK-1006 (Drug)
MK-1006 80 mg Once Daily (Panel C)
After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
干预措施: MK-1006 (Drug)
MK-1006 120 mg Once Daily (Panel D)
After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
干预措施: MK-1006 (Drug)
MK-1006 20 mg Twice Daily (Panel E)
After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
干预措施: MK-1006 (Drug)
MK-1006 30 mg Twice Daily (Panel F)
After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
干预措施: MK-1006 (Drug)
MK-1006 50 mg Twice Daily (Panel G)
After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
干预措施: MK-1006 (Drug)
MK-1006 120 mg Once Daily Outpatient (Panel H)
After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
干预措施: MK-1006 (Drug)
MK-1006 50 mg Twice Daily Outpatient (Panel I)
After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
干预措施: MK-1006 (Drug)
结局指标
主要结局
Number of Participants Experiencing Adverse Events (AEs) On Study
时间窗: From Day 1 through the end of poststudy period (up to Day 25)
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the study treatment, was also an adverse event.
Number of Participants Who Discontinued Treatment Due to an AE
时间窗: From Day 1 through the end of poststudy period (up to Day 25)
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the study treatment, was also an adverse event.
次要结局
- Least Squares Mean Change From Baseline in 24-Hour Weighted Mean Glucose (WMG)(Day -1 (pre-dose baseline), Day 1 (First Dosing Day), Day 10 (Last Dosing Day))