An Open-Label, Randomized, Partially Fixed-Sequence, 4-Period Crossover Study to Assess the Pharmacokinetics After Administration of the DFC and OCT Formulations and the Food Effect on the OCT Formulation of MK-0941 in Patients With Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Area Under the Curve (AUC)(0-∞) for Oral Compressed Tablet (OCT) (Fasted) and Dry Filled Capsule (DFC) (Fasted)
研究概览
简要总结
A study to compare the pharmacokinetics (PK) of the dry filled capsule (DFC) & oral compressed tablet (OCT) formulations of MK-0941-009 & to assess the effect of food on the OCT formulation.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females (of non-childbearing potential) between the ages of 18 to 70
- •Participants have been diagnosed with Type 2 Diabetes
- •Participants are nonsmokers for at least 6 months
排除标准
- •Participant should not be diagnosed with Type 1 diabetes
- •Participant should not be receiving insulin or PPAR gamma agonists for 12 weeks prior to study start
- •Participant has a recent history of eye infection or other inflammatory eye condition within 2 weeks prior to study start
- •Participant has been diagnosed with glaucoma or is blind
- •Participant has had trauma to one or both eyes
- •Participant has had major surgery, donated blood or participated in another clinical study in the past 4 weeks
- •Participant is a regular user of illicit drugs or has a history of drug, including alcohol, abuse in the past 6 months
研究组 & 干预措施
DFC (fasted)
干预措施: 10 mg MK-0941 DFC (fasted) (Drug)
OCT (fasted)
干预措施: 10 mg MK-0941 OCT (fasted) (Drug)
OCT (after meal)
干预措施: 10 mg MK-0941 OCT (after meal) (Drug)
OCT (before meal)
干预措施: 10 mg MK-0941 OCT (before meal) (Drug)
结局指标
主要结局
Area Under the Curve (AUC)(0-∞) for Oral Compressed Tablet (OCT) (Fasted) and Dry Filled Capsule (DFC) (Fasted)
时间窗: From study drug administration to 72 hours post-administration
Maximum Concentration (Cmax) for OCT (Fasted) and DFC (Fasted)
时间窗: From study drug administration to 72 hours post-administration
Time to Reach Cmax (Tmax) for OCT (Fasted) and DFC (Fasted)
时间窗: From study drug administration to 72 hours post-administration
Half Life (t½) for OCT (Fasted) and DFC (Fasted)
时间窗: From study drug administration to 72 hours post-administration
次要结局
- AUC(0-∞) for OCT (Fasted) and OCT (After Meal)(From study drug administration to 72 hours post-administration)
- Cmax of OCT (Fasted) and OCT (After Meal)(From study drug administration to 72 hours post-administration)
- Tmax for OCT (Fasted) and OCT (After Meal)(From study drug administration to 72 hours post-administration)
- t1/2 for OCT (Fasted) and OCT (After Meal)(From study drug administration to 72 hours post-administration)