A Study of Safety, Tolerability, and Pharmacokinetics of Multiple-Dose CC-90001 in Japanese and Caucasian Healthy Subjects
A PHASE 1, OPEN LABEL STUDY TO EVALUATE THE PHARMACOKINETICS AND SAFETY/TOLERABILITY OF CC-90001 IN JAPANESE HEALTHY SUBJECTS
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).
研究概览
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
-
-
California
-
Glendale、California、美国、91206
- Paraxel International
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:CC-90001 100 mg
100 mg of CC-90001 (once daily [QD] x 7 days) will be given orally
|
CC-90001
|
|
实验性的:CC-90001 200 mg
200 mg of CC-90001 (once daily [QD] x 7 days) will be given orally
|
CC-90001
|
|
实验性的:CC-90001 400 mg
400 mg of CC-90001 (once daily [QD] x 7 days) will be given orally
|
CC-90001
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pharmacokinetic- AUC0-t
大体时间: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
|
Day 1 and Day 7- 10
|
|
Pharmacokinetic- AUC0-∞
大体时间:Day 1 and Day 7- 10
|
Area under the plasma concentration-time curve from time zero to infinity
|
Day 1 and Day 7- 10
|
|
Pharmacokinetic- CL/F
大体时间:Day 1 and Day 7- 10
|
Estimation of apparent clearance of drug from plasma after extravascular administration
|
Day 1 and Day 7- 10
|
|
Pharmacokinetic- Vz/F
大体时间:Day 1 and Day 7- 10
|
Estimation of apparent volume of distribution during the terminal phase
|
Day 1 and Day 7- 10
|
|
Pharmacokinetic- Cmax
大体时间:Day 1 and Day 7
|
Estimation of observed maximum plasma concentration
|
Day 1 and Day 7
|
|
Pharmacokinetic- Tmax
大体时间:Day 1 and Day 7
|
Estimation of time to Cmax
|
Day 1 and Day 7
|
|
Pharmacokinetic- t1/2
大体时间:Day 1 and Day 7- 10
|
Description: Estimation of terminal elimination half-life
|
Day 1 and Day 7- 10
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Adverse Events (AEs)
大体时间:From enrollment until at least 28 days after completion of study treatment
|
Number participants with Adverse Event
|
From enrollment until at least 28 days after completion of study treatment
|
合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:
https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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