NCT01614782终止1 期
A Multiple Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-5823 in Healthy Overweight/Obese Subjects and Patients With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 24
- 主要终点
- Number of participants who experienced at least one adverse event
研究概览
简要总结
The purpose of this study is to assess the multiple rising dose safety/tolerability and pharmacokinetics of MK-5823 in overweight/obese participants who are healthy and overweight/obese participants with Type 2 diabetes mellitus (T2DM).
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
- 是
入选标准
- •Male or female of non-childbearing potential
- •A Body Mass Index between 27 and 35 kg/m^2 and weighs at least 50 kg
- •Judged to be in good health and for the T2DM Panels, good health other than the diagnosis of T2DM
- •For T2DM Panels only: has a diagnosis of T2DM and is being treated with lifestyle management (e.g. diet and exercise) alone or in combination with a stable dose of metformin
- •A nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months
排除标准
- •History of stroke, chronic seizures or major neurological disorder
- •History of clinically significant gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases.
- •History of clinically significant endocrine abnormalities or diseases (including type I or type II, or steroid-induced diabetes for healthy participant panel; and excluding T2DM for the T2DM Panels)
- •Irritable bowel syndrome, or recurrent nausea, vomiting, diarrhea, or abdominal pain.
- •History of neoplastic disease
- •History of cataracts, diabetic retinopathy, macular edema, macular degeneration, vitreous hemorrhage, glaucoma, ocular surgery, ocular trauma or blindness
- •Requires treatment with systemic or ocular corticosteroids
- •For T2DM Panels, a history of hypoglycemic unawareness
- •For T2DM Panels, active treatment with any anti-hyperglycemic drug other than metformin
- •For T2DM Panels, treatment with any peroxisome proliferator-activated receptor-gamma agonist (e.g. Avandia or Actos) within 12 weeks of study participation
- •Unable to refrain from using any medication beginning 2 weeks before study participation
- •Consumes excessive amounts of alcohol (>3 per day)
- •Consumes more than 6 caffeinated beverages per day
- •Had major surgery or donated or lost more than 1 unit of blood
- •Participated in another investigational study within 4 weeks of study participation
- •History of significant multiple and/or severe allergies or anaphylactic reaction
- •Hypersensitivity to glucagon or insulin
- •Uses illicit drugs or has a history of drug or alcohol abuse within 3 months of study participation
- •Woman of child-bearing potential or is a nursing mother
- •For T2DM Panels, age >50 years
研究组 & 干预措施
0.35 mg MK-5823 - Healthy Participants
Experimental
干预措施: MK-5823 (Drug)
1.4 mg MK-5823 - Participants with T2DM
Experimental
干预措施: MK-5823 (Drug)
0.35 mg MK-5823 - Healthy Participants
Experimental
干预措施: Placebo (Other)
0.7 mg MK-5823 - Healthy Participants
Experimental
干预措施: MK-5823 (Drug)
0.7 mg MK-5823 - Healthy Participants
Experimental
干预措施: Placebo (Other)
1.4 mg MK-5823 - Healthy Participants
Experimental
干预措施: MK-5823 (Drug)
1.4 mg MK-5823 - Healthy Participants
Experimental
干预措施: Placebo (Other)
2.8 mg MK-5823 - Healthy Participants
Experimental
干预措施: MK-5823 (Drug)
2.8 mg MK-5823 - Healthy Participants
Experimental
干预措施: Placebo (Other)
1.4 mg MK-5823 - Participants with T2DM
Experimental
干预措施: Placebo (Other)
2.8 mg MK-5823 - Participants with T2DM
Experimental
干预措施: MK-5823 (Drug)
2.8 mg MK-5823 - Participants with T2DM
Experimental
干预措施: Placebo (Other)
结局指标
主要结局
Number of participants who experienced at least one adverse event
时间窗: Up to 49 days
Number of participants who discontinued from study drug due to an adverse event
时间窗: Up to 21 days
次要结局
- Maximum plasma concentration (Cmax) following once daily administration of MK-5823(Predose on Day 1 (baseline) through 672 hours following the initial dose)
- Area under the plasma concentration time curve from Hour 0 to Hour 24 (AUC0-24) following once daily administration of MK-5823(Predose on Day 1 (baseline) through 672 hours following the initial dose)
- Lowest plasma concentration (Ctrough) following once daily administration of MK-5823(Predose on Day 1 (baseline) through 672 hours following the initial dose)
- Time to maximum plasma concentration (Tmax) following once daily administration of MK-5823(Predose on Day 1 (baseline) through 672 hours following the initial dose)
- Apparent terminal half-life (apparent t1/2) following once daily administration of MK-5823(Predose on Day 1 (baseline) through 672 hours following the initial dose)
研究者
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