A Single Dose Study to Compare the Pharmacokinetics of Two Probe Formulations of MK-1006
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Area Under the Concentration Versus Time Curve (AUC(0-infinity)) for MK-1006
研究概览
简要总结
This study will assess the pharmacokinetics of two formulations of MK-1006. The primary hypothesis of this study is that the MK-1006 area under the curve (0 to infinity) and maximum concentration after administration of a single 80 mg dose of the dry filled capsule (DFC) and film coated tablet (FCT) formulations of MK-1006 will be similar.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •is a male or a female of non-child bearing potential
- •has type 2 diabetes (T2D) and is either being treated with diet and exercise alone or with a single or combination oral anti-hyperglycemic agent(s)
- •has been a nonsmoker for at least 6 months
排除标准
- •has a history of stroke, chronic seizures, or major neurological disorder
- •has a history of major endocrine (except T2D), gastrointestinal, cardiovascular, blood, liver, immune, kidney, respiratory, or genitourinary abnormalities or diseases
- •has a history of cancer, except certain skin or cervical cancers or cancer that was successfully treated more than 10 years prior to screening
- •has unstable or rapidly progressing diabetic retinopathy and/or neuropathy
- •has had an eye infection or other inflammation of the eye in the 2 weeks prior to screening
- •has glaucoma or is blind
- •has had incisional eye surgery in the last 6 months or laser eye surgery in the last 3 months (Lasik is permitted)
- •has a history of type 1 diabetes
- •has symptomatic coronary artery disease
- •consumes excessive amounts of alcohol and/or caffeine
研究组 & 干预措施
MK-1006 80 mg DFC
Participants received a single dose of four 20 mg dry filled capsules of MK-1006
干预措施: MK-1006 DFC (Drug)
MK-1006 80 mg FCT
Participants received a single dose of two 40 mg film coated tablets of MK-1006
干预措施: MK-1006 FCT (Drug)
结局指标
主要结局
Area Under the Concentration Versus Time Curve (AUC(0-infinity)) for MK-1006
时间窗: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose
AUC (0-infinity) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for two formulations of MK-1006, FCT and DFC
Maximum Plasma Concentration (Cmax) for MK-1006
时间窗: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose
Maximum plasma concentration for 2 formulations of MK-1006, FCT and DFC
次要结局
- Number of Participants Who Experienced at Least One Adverse Event(Through 30 days post-dose)
- Number of Participants Who Discontinued Study Medication Due to an Adverse Event(up to 8 days)