A PHASE 1, OPEN LABEL STUDY TO EVALUATE THE PHARMACOKINETICS AND SAFETY/TOLERABILITY OF CC-90001 IN JAPANESE HEALTHY SUBJECTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pharmacokinetic- AUC0-t
研究概览
简要总结
This is a Phase 1, open-label, randomized, parallel design study to evaluate the PK and safety/tolerability of CC 90001 in Japanese and Caucasian healthy adult subjects.
The study will consist of multiple oral doses of IP (QD x 7 days) in 3 planned dose level cohorts of 100 mg, 200 mg, and 400 mg. Each cohort will have 20 subjects (10 Japanese subjects and 10 Caucasian subjects, with a minimum of 8 subjects to complete in each group) who will receive IP (see below).
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
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must satisfy all of the following criteria to be enrolled in the study:
- •Healthy, adult, male and female subjects.
- •Japanese subjects who were born in Japan and not have lived outside of Japan for more than 10 years, have both parents and grandparents of Japanese origin, and have not significantly modified their diets since leaving Japan.
- •Caucasian subjects who have age and body mass index matched with Japanese subjects.
排除标准
- •Has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study or place the subject at unacceptable risk if he/she were to participate in the study.
- •Use of any prescribed systemic or topical medication within 30 days of the first dose administration.
- •Has any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, and excretion.
研究组 & 干预措施
CC-90001 100 mg
100 mg of CC-90001 (once daily [QD] x 7 days) will be given orally
干预措施: CC-90001 (Drug)
CC-90001 200 mg
200 mg of CC-90001 (once daily [QD] x 7 days) will be given orally
干预措施: CC-90001 (Drug)
CC-90001 400 mg
400 mg of CC-90001 (once daily [QD] x 7 days) will be given orally
干预措施: CC-90001 (Drug)
结局指标
主要结局
Pharmacokinetic- AUC0-t
时间窗: Day 1 and Day 7- 10
Area under the plasma concentration-time curve from time zero to the time point of the last measurable concentration
Pharmacokinetic- CL/F
时间窗: Day 1 and Day 7- 10
Estimation of apparent clearance of drug from plasma after extravascular administration
Pharmacokinetic- Tmax
时间窗: Day 1 and Day 7
Estimation of time to Cmax
Pharmacokinetic- AUC0-∞
时间窗: Day 1 and Day 7- 10
Area under the plasma concentration-time curve from time zero to infinity
Pharmacokinetic- Cmax
时间窗: Day 1 and Day 7
Estimation of observed maximum plasma concentration
Pharmacokinetic- t1/2
时间窗: Day 1 and Day 7- 10
Description: Estimation of terminal elimination half-life
Pharmacokinetic- Vz/F
时间窗: Day 1 and Day 7- 10
Estimation of apparent volume of distribution during the terminal phase
次要结局
- Adverse Events (AEs)(From enrollment until at least 28 days after completion of study treatment)