NCT01156077已完成1 期
A Phase 1, Open-Label, Multi-Center, Two-Part, Single-Dose, Parallel Design, Safety, Tolerance, and Pharmacokinetic Study of Orally and Intravenously Administered TR-701 FA in 12 to 17 Year Old Adolescent Patients
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)0 个研究点目标入组 20 人开始时间: 2010年6月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Adolescent PK
研究概览
简要总结
This is an open-label, multi-center, two-part, parallel-design study to assess the PK, safety, and tolerability of TR-701 FA and its active metabolite, TR-700, following a single oral dose (Part A) or IV dose (Part B) of TR-701 FA in 12 to 17 year old adolescent patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males and females, between 12 and 17 years of age, inclusive;
- •receiving prophylaxis for or have a confirmed or suspected infection with Gram positive bacteria and receiving concurrent antibiotic treatment with Gram positive antibacterial activity
- •in stable condition
- •females must be premenarchal, surgically sterile, abstinent, or practicing an effective method of birth control
- •males will either be surgically sterile, abstinent, or practicing an effective method of birth control
排除标准
- •relevant history of seizures, clinically significant cardiac arrhythmia, cystic fibrosis, moderate or severe renal impairment, or any physical condition that could interfere with the interpretation of the study results
- •any acute or chronic condition that, in the opinion of the Investigator, would limit the patient's ability to complete and/or participate in this clinical study
- •physician-diagnosed migraine headaches
- •history of infection with hepatitis or other significant hepatic disease
- •females who are pregnant or breast feeding
研究组 & 干预措施
oral TR-701 FA
Experimental
Single oral dose of 200 mg TR-701
干预措施: TR-701 FA (Drug)
IV TR-701 FA
Experimental
Single IV infusion of 200 mg TR-701 FA
干预措施: TR-701 FA (Drug)
结局指标
主要结局
Adolescent PK
时间窗: 2 days
To describe the single-dose pharmacokinetics (PK) of IV and oral TR-701 FA administration in 12 to 17 year old adolescent patients, based on the individual plasma and urine concentration-time data.
次要结局
未报告次要终点
研究者
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