NCT00646789已完成1 期
A Multicenter, Open-Label, Single Dose Study to Evaluate the Safety, Tolerability and Plasma Concentration Profiles of MK0633 in Asthmatic Children Aged 12 to Less Than 16 Years
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- To evaluate the safety and tolerability of MK0633 in adolescent asthma patients.
研究概览
简要总结
To evaluate the safety, tolerability and pharmacokinetics (PK) of MK0633 in adolescent mild-to-moderate asthma patients to permit further clinical investigation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient is judged to be in good health, other than having mild to moderate asthma, based on medical history, physical examination, vital signs, and laboratory safety tests
- •Patient has no clinically significant abnormality on electrocardiogram (ECG) performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug
- •Patient has at least 1 year of mild-to-moderate asthma
- •Patient has been a nonsmoker for at least 6 months
- •Patients of childbearing potential must agree to use a medically acceptable method of contraception during the study and for 90 days after the last dose of study drug
- •Patients must be able to swallow tablets
排除标准
- •Patient has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, other than asthma, or genitourinary abnormalities or diseases
- •Patient has required a visit to a hospital or emergency room due to an asthma exacerbation within 3 months of the prestudy visit
- •Patient has unresolved signs and symptoms of an upper respiratory tract infection (URI) or has had had an upper respiratory tract infection within 3 weeks prior to the prestudy visit
- •Patient has a history of stroke, chronic seizures, or major neurological disorder
- •Patient has a history of neoplastic disease
- •Use of theophylline, Singulair (montelukast), Xolair (omalizumab), Zyflo amd Zyflo CR (zileuton), oral corticosteroids and oral beta agonists are excluded approximately 2 weeks prior to administration of study drug and throughout the study
- •Patient consumes alcoholic beverages
结局指标
主要结局
To evaluate the safety and tolerability of MK0633 in adolescent asthma patients.
时间窗: Blood and urine samples will be collected at specified intervals for 72 hours after study drug administration.
次要结局
未报告次要终点
研究者
相似试验
已完成
1 期
MK0633 Single Dose Study in Japanese Asthmatic Children Aged 12 to Less Than 16 Years (0633-028)AsthmaNCT00768170Merck Sharp & Dohme LLC10
已完成
1 期
Plasma Levels of MK0633 in Children Ages 6-12 (0633-023)AsthmaNCT00751413Merck Sharp & Dohme LLC22
已完成
1 期
A Study of MK-6837 as a Monotherapy and Combination Therapy in Participants With Advanced/Metastatic Solid Tumors (MK-6837-001)Neoplasm MetastasisNCT06460961Merck Sharp & Dohme LLC40
终止
1 期
A Single-Dose Study of MK6349 in Patients With Type 2 Diabetes (6349-002)Type 2 Diabetes MellitusNCT00943371Merck Sharp & Dohme LLC28
已完成
1 期
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK0683 in Patients With Advanced Cancer (0683-008)Cancer, AdvancedNCT00750178Merck Sharp & Dohme LLC30