A Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-5823 in Overweight or Obese Participants Who Are Healthy or Have Type 2 Diabetes Mellitus (MK-5823-002)
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
研究概览
研究类型
注册 (实际的)
阶段
- 阶段1
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：0.35 mg MK-5823 - Healthy Participants
|
MK-5823 administered subcutaneously (doses ranging from 0.35 mg to 2.8 mg) once daily for 3 weeks. Doses may be adjusted downward based on safety, tolerability, and/or pharmacokinetic data. The decision to dose escalate will be based on accrued safety/tolerability data at the prior dose level. In each arm, 6 participants will be randomized to receive study drug and 2 participants will be randomized to receive placebo.
Matching placebo to MK-5823 administered subcutaneously once daily for 3 weeks.
|
|
实验性的：0.7 mg MK-5823 - Healthy Participants
|
MK-5823 administered subcutaneously (doses ranging from 0.35 mg to 2.8 mg) once daily for 3 weeks. Doses may be adjusted downward based on safety, tolerability, and/or pharmacokinetic data. The decision to dose escalate will be based on accrued safety/tolerability data at the prior dose level. In each arm, 6 participants will be randomized to receive study drug and 2 participants will be randomized to receive placebo.
Matching placebo to MK-5823 administered subcutaneously once daily for 3 weeks.
|
|
实验性的：1.4 mg MK-5823 - Healthy Participants
|
MK-5823 administered subcutaneously (doses ranging from 0.35 mg to 2.8 mg) once daily for 3 weeks. Doses may be adjusted downward based on safety, tolerability, and/or pharmacokinetic data. The decision to dose escalate will be based on accrued safety/tolerability data at the prior dose level. In each arm, 6 participants will be randomized to receive study drug and 2 participants will be randomized to receive placebo.
Matching placebo to MK-5823 administered subcutaneously once daily for 3 weeks.
|
|
实验性的：2.8 mg MK-5823 - Healthy Participants
|
MK-5823 administered subcutaneously (doses ranging from 0.35 mg to 2.8 mg) once daily for 3 weeks. Doses may be adjusted downward based on safety, tolerability, and/or pharmacokinetic data. The decision to dose escalate will be based on accrued safety/tolerability data at the prior dose level. In each arm, 6 participants will be randomized to receive study drug and 2 participants will be randomized to receive placebo.
Matching placebo to MK-5823 administered subcutaneously once daily for 3 weeks.
|
|
实验性的：1.4 mg MK-5823 - Participants with T2DM
|
MK-5823 administered subcutaneously (doses ranging from 0.35 mg to 2.8 mg) once daily for 3 weeks. Doses may be adjusted downward based on safety, tolerability, and/or pharmacokinetic data. The decision to dose escalate will be based on accrued safety/tolerability data at the prior dose level. In each arm, 6 participants will be randomized to receive study drug and 2 participants will be randomized to receive placebo.
Matching placebo to MK-5823 administered subcutaneously once daily for 3 weeks.
|
|
实验性的：2.8 mg MK-5823 - Participants with T2DM
|
MK-5823 administered subcutaneously (doses ranging from 0.35 mg to 2.8 mg) once daily for 3 weeks. Doses may be adjusted downward based on safety, tolerability, and/or pharmacokinetic data. The decision to dose escalate will be based on accrued safety/tolerability data at the prior dose level. In each arm, 6 participants will be randomized to receive study drug and 2 participants will be randomized to receive placebo.
Matching placebo to MK-5823 administered subcutaneously once daily for 3 weeks.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Number of participants who experienced at least one adverse event
大体时间：Up to 49 days
|
Up to 49 days
|
|
Number of participants who discontinued from study drug due to an adverse event
大体时间：Up to 21 days
|
Up to 21 days
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Area under the plasma concentration time curve from Hour 0 to Hour 24 (AUC0-24) following once daily administration of MK-5823
大体时间：Predose on Day 1 (baseline) through 672 hours following the initial dose
|
Predose on Day 1 (baseline) through 672 hours following the initial dose
|
|
Maximum plasma concentration (Cmax) following once daily administration of MK-5823
大体时间：Predose on Day 1 (baseline) through 672 hours following the initial dose
|
Predose on Day 1 (baseline) through 672 hours following the initial dose
|
|
Lowest plasma concentration (Ctrough) following once daily administration of MK-5823
大体时间：Predose on Day 1 (baseline) through 672 hours following the initial dose
|
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
大体时间：Predose on Day 1 (baseline) through 672 hours following the initial dose
|
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
大体时间：Predose on Day 1 (baseline) through 672 hours following the initial dose
|
Predose on Day 1 (baseline) through 672 hours following the initial dose
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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MK-5823的临床试验
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Merck Sharp & Dohme LLC终止
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