A Phase 1, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Pomalidomide (CC-4047) Following Multiple Daily Doses in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- area under the plasma concentration-time curve
研究概览
简要总结
To evaluate the safety, tolerability, and pharmacokinetics of pomalidomide administered orally once a day for 5 days, at daily doses of 0.5 mg, 1 mg, or 2 mg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects of any ethnic origin between ages of 18 and 55 with a body mass index between 19 and 30
排除标准
- •Any condition, including the presence of laboratory abnormalities, or psychiatric illness, that would prevent the subject from signing the Informed Consent Document (ICD), places the subject at unacceptable risk if he were to participate in the study, or confounds the ability to interpret data from the study.
- •Presence of any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, and excretion, or plans to have elective or medical procedures during the conduct of the trial.
- •Exposure to an investigational drug (new chemical entity) within 30 days prior to the first dose administration or 5 half-lives of that investigational drug, if known (whichever is longer).
研究组 & 干预措施
0.5-mg Pomalidomide or placebo (Cohort A)
A single 0.5-mg pomalidomide capsule or matching placebo administered once daily for 5 days under fasted conditions
干预措施: Pomalidomide (Drug)
0.5-mg Pomalidomide or placebo (Cohort A)
A single 0.5-mg pomalidomide capsule or matching placebo administered once daily for 5 days under fasted conditions
干预措施: Placebo (Drug)
1-mg Pomalidomide or placebo (Cohort B)
This arm may be initiated pending a safety review of Cohort A. A single 1-mg pomalidomide capsule or matching placebo administered once daily for 5 days under fasted conditions.
干预措施: Pomalidomide (Drug)
1-mg Pomalidomide or placebo (Cohort B)
This arm may be initiated pending a safety review of Cohort A. A single 1-mg pomalidomide capsule or matching placebo administered once daily for 5 days under fasted conditions.
干预措施: Placebo (Drug)
2-mg Pomalidomide or placebo (Cohort C)
This arm may be initiated pending a safety review of Cohort B. A single 2-mg pomalidomide capsule or matching placebo administered once daily for 5 days under fasted conditions.
干预措施: Pomalidomide (Drug)
2-mg Pomalidomide or placebo (Cohort C)
This arm may be initiated pending a safety review of Cohort B. A single 2-mg pomalidomide capsule or matching placebo administered once daily for 5 days under fasted conditions.
干预措施: Placebo (Drug)
结局指标
主要结局
area under the plasma concentration-time curve
时间窗: 72 hours after last dose
area under the plasma concentration-time curve
Number of participants with adverse events
时间窗: 28 days after last dose
Number of participants with adverse events
time to maximum observed plasma concentration
时间窗: 72 hours after last dose
time to maximum observed plasma concentration
次要结局
- maximum observed plasma concentration(72 hours after last dose)
- terminal elimination half-life(72 hours after last dose)
- apparent total plasma clearance(72 hours after last dose)
- apparent total volume of distribution, and accumulation ratio(72 hours after last dose)