NCT00968422已完成1 期
A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-384 in Elderly Subjects
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
- Abbott
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)
研究概览
简要总结
The objectives of this study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ABT-384 in elderly subjects.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age is 65 years or greater
- •Judged to be in a condition of general good health based on the results of medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG
排除标准
- •Use of protocol-prohibited medications within 2 weeks prior to study drug administration.
- •Positive urine drug screen for non-prescribed drugs of abuse including alcohol.
- •Receipt of any drug depot by injection within 30 days prior to study drug administration.
- •Receipt of any investigational product within 6 weeks prior to study drug administration.
- •History of significant sensitivity or allergy to any drug.
- •History of drug or alcohol abuse within 2 years.
- •Positive test result for HBV, HCV or HIV.
- •Estimated creatinine clearance < 30 mL/min.
- •Donation or loss of 5 mL/kg or more blood volume or receipt of any blood product within 8 weeks prior to study drug administration.
- •Current enrollment in another clinical study.
研究组 & 干预措施
Low dose ABT-384
Experimental
干预措施: ABT-384 (Drug)
Mid dose ABT-384
Experimental
干预措施: ABT-384 (Drug)
High dose ABT-384
Experimental
干预措施: ABT-384 (Drug)
Placebo
Placebo Comparator
干预措施: Matching placebo to ABT-384 (Drug)
结局指标
主要结局
Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)
时间窗: Days -2 through 84
Assess Pharmacokinetics (i.e., ABT-384 and possible metabolite levels) and Pharmacodynamics (i.e., biomarkers of drug effect)
时间窗: Days -1 through 27
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ABT-436 in Healthy AdultsHealthyNCT01050127Abbott36
已完成
1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 135585 XX in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT01282970Boehringer Ingelheim72
已完成
1 期
Single Rising Dose Study of BI 135585 XX in Health Asian Male Volunteers.HealthyNCT01291732Boehringer Ingelheim48
Unknown
1 期
A Safety，Tolerability and Pharmacokinetics Clinical Trial of JX11502MA CapsuleSchizophreniaNCT05233657Zhejiang Jingxin Pharmaceutical Co., Ltd.58
已完成
1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1356 BS Administered to Healthy Male SubjectsHealthyNCT02173665Boehringer Ingelheim64