A Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-0941 in Japanese Patients With Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- Number of Participants Who Experienced at Least One Adverse Event (AE)
研究概览
简要总结
The multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-0941 in Japanese patients 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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese Male or Female between 20 to 65 years of age
- •Diagnosis of Type 2 Diabetes
- •Patient being treated by diet and exercise alone
排除标准
- •Patient has a history of Type 1 Diabetes
- •Patient is being treated with glaucoma medications
- •Patient has donated blood or participated in another clinical study in the past 12 weeks
- •Patient is a regular user of any illicit drugs or has a history of drug, including alcohol, abuse
研究组 & 干预措施
Placebo/MK-0941 20mg
Participants received Placebo during Period 1 and MK-0941 20 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods.
干预措施: Placebo (Drug)
Placebo/MK-0941 20mg
Participants received Placebo during Period 1 and MK-0941 20 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods.
干预措施: MK-0941 (Drug)
MK-0941 5mg/Placebo
Participants received MK-0941 5 mg during Period 1 and Placebo during Period 2. There was a washout period of at least 8 days between the two treatment periods.
干预措施: Placebo (Drug)
MK-0941 5mg/Placebo
Participants received MK-0941 5 mg during Period 1 and Placebo during Period 2. There was a washout period of at least 8 days between the two treatment periods.
干预措施: MK-0941 (Drug)
MK-0941 5mg/MK-0941 20mg
Participants received MK-0941 5 mg during Period 1 and MK-0941 20 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods.
干预措施: MK-0941 (Drug)
Placebo/MK-0941 40mg
Participants received Placebo during Period 1 and MK-0941 40 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods.
干预措施: Placebo (Drug)
Placebo/MK-0941 40mg
Participants received Placebo during Period 1 and MK-0941 40 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods.
干预措施: MK-0941 (Drug)
MK-0941 10mg/Placebo
Participants received MK-0941 10 mg during Period 1 and Placebo during Period 2. There was a washout period of at least 8 days between the two treatment periods.
干预措施: Placebo (Drug)
MK-0941 10mg/Placebo
Participants received MK-0941 10 mg during Period 1 and Placebo during Period 2. There was a washout period of at least 8 days between the two treatment periods.
干预措施: MK-0941 (Drug)
MK-0941 10mg/MK-0941 40mg
Participants received MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods.
干预措施: MK-0941 (Drug)
结局指标
主要结局
Number of Participants Who Experienced at Least One Adverse Event (AE)
时间窗: Up to 14 days after last dose of study drug
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
Number of Participants Who Discontinued Study Drug Due to an AE
时间窗: Up to 14 days after last dose of study drug
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
次要结局
- Plasma Pharmacokinetic Parameter: Area Under the Concentration-time Curve (AUC)(0-24hr) of MK-0941(Up to 72 hours after study drug administration)
- Plasma Pharmacokinetic Parameter: Apparent Terminal Elimination Half-life (t1/2) of MK-0941(Up to 72 hours after study drug administration)
- Plasma Pharmacokinetic Parameter: Maximum Concentration (Cmax) of MK-0941(Up to 72 hours after study drug administration)
- Plasma Pharmacokinetic Parameter: Day 5 to Day 1 Accumulation Ratio for AUC (0-24hr), Cmax, and C24hr(Day 5 and Day 1)
- Plasma Pharmacokinetic Parameter: Time to Reach Cmax (Tmax) of MK-0941(Up to 72 hours after study drug administration)
- Plasma Pharmacokinetic Parameter: Concentration of MK-0941 at 24 Hours (C24hr)(Up to 72 hours after study drug administration)