NCT02998099已完成1 期
A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, PARALLEL-GROUP SINGLE-DOSE STUDY TO ESTIMATE THE EFFECT OF AGE ON THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF INTRAVENOUS RIVIPANSEL (PF-06460031)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration-time profile from time 0 extrapolated to infinite time or area under the plasma concentration-time from time 0 to time of the last quantifiable concentration as data permit.
研究概览
简要总结
The purpose of this study is to evaluate the effect of age on PK, safety and tolerability of IV rivipansel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy female subjects of non-childbearing potential or healthy male subjects who are between the ages of 18-45 years or 65 years of age or older.
- •Body mass index (BMI) of 17.5 to 40 kg/m2
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- •Pregnant females; breastfeeding female subjects; male subjects with partners currently pregnant
- •Treatment with another investigational drug within 30 days or 5 half-lives preceding the dose of study medication
- •Blood donation within 60 days prior to dosing.
研究组 & 干预措施
Aged 18-45 years
Experimental
A single dose of IV rivipansel over 20 minutes.
干预措施: Rivipansel (Drug)
Aged 65 and older
Experimental
A single dose of IV rivipansel over 20 minutes.
干预措施: Rivipansel (Drug)
结局指标
主要结局
Area under the plasma concentration-time profile from time 0 extrapolated to infinite time or area under the plasma concentration-time from time 0 to time of the last quantifiable concentration as data permit.
时间窗: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48 and 72 hours following single dose administration of IV rivipansel
Clearance (CL)
时间窗: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48 and 72 hours following single dose administration of rivipansel.
次要结局
- Area under the plasma concentration-time profile from time 0 to time of last quantifiable concentration(Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48 and 72 hours following single dose administration of rivipansel.)
- Maximum plasma concentration(Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48 and 72 hours following single dose administration of rivipansel.)
- Mean elimination half-life(Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48 and 72 hours following single dose administration of rivipansel.)
- Volume of distribution at steady state(Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48 and 72 hours following single dose administration of rivipansel.)
- Physical examination(Baseline up to 72 hours)
- Assessment of adverse events(Baseline up to 28 days)
- Assessment of 12-lead electrocardiogram(Baseline up to 72 hours)
- Assessment of vital signs(Baseline up to 72 hours)
- Assessment of laboratory tests(Baseline up to 72 hours)
研究者
研究点 (1)
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