NCT00909688已完成1 期
Ascending Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of BLI-489 Administered Intravenously to Healthy Subjects
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 16 人开始时间: 2009年6月5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
- 16
- 主要终点
- Assess safety of drug given to healthy subjects by evaluating any reported adverse events (AEs), scheduled physical examinations, vital sign measurements, 12-lead ECGs, and clinical laboratory test results.
研究概览
简要总结
To determine the safety, tolerability, and drug absorption profile of multiple IV doses of BLI 489 in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women of non-childbearing potential (WONCBP) aged 18 to 50 years inclusive at screening;
- •Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight ≥50 kg.;
- •Healthy as determined by the investigator on the basis of screening evaluations;
- •Calculated creatinine clearance within normal limits using the Cockcroft-Gault formula;
- •Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history, and if a smoker must be able to abstain from smoking during the inpatient stay;
- •Have a high probability for compliance with and completion of the study.
排除标准
- •Presence or history of any disorder that may prevent the successful completion of the study;
- •Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease;
- •Any surgical or medical condition that may interfere with the distribution, metabolism, or excretion of the investigational product;
- •Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1;
- •History of drug abuse within 1 year before study day 1;
- •Admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements.
研究组 & 干预措施
1
Experimental
BLI-489
干预措施: BLI-489 (Drug)
2
Placebo Comparator
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Assess safety of drug given to healthy subjects by evaluating any reported adverse events (AEs), scheduled physical examinations, vital sign measurements, 12-lead ECGs, and clinical laboratory test results.
时间窗: 4 months
次要结局
未报告次要终点
研究者
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