A Study to Evaluate the Effect of a Proton-Pump Inhibitor (Rabeprazole) on the Relative Bioavailability of Cobimetinib in Healthy Participants
2017年4月4日 更新者:Genentech, Inc.
A Phase 1, Open-Label, 3-Period, Randomized, Crossover Study to Evaluate the Effect of a Proton-Pump Inhibitor (Rabeprazole) on the Relative Bioavailability of GDC-0973 in Healthy Subjects
This is a Phase 1, single-center, open-label, randomized, 3-period, 2-sequence crossover study of cobimetinib in healthy participants to evaluate the effect of the proton-pump inhibitor (PPI) rabeprazole on the relative bioavailability of cobimetinib in healthy participants when administered in the fed or fasted states.
研究概览
研究类型
介入性
注册 (实际的)
20
阶段
- 阶段1
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 55年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria
- With a body mass index range of 18.5 to 29.9 kilograms per meter square (kg/m^2)
- In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), and vital signs
- Clinical laboratory evaluations within the reference range for the test laboratory
- Negative test for selected drugs of abuse at Screening (does not include alcohol) and at each Check-in
- Negative hepatitis panel (including hepatitis B virus surface antigen [HBsAg] and hepatitis C virus antibody [anti-HCV]) and negative human immunodeficiency virus (HIV) antibody screens
- Healthy males and females of nonchildbearing potential who agree to use effective contraception
Exclusion Criteria
- Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs, except that appendectomy, hernia repair, and/or cholecystectomy will be allowed
- History or presence of an abnormal ECG
- History of alcoholism or drug addiction within 1 year prior to Period 1 Check-in
- Use of any tobacco- or nicotine-containing products within 6 months prior to Period 1 Check-in
- Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days or 5 half-lives, whichever is longer, prior to Period 1 Check-in
- Use of any prescription medications/products within 14 days prior to Period 1 Check-in
- Use of any over-the-counter, non-prescription preparations within 7 days prior to Period 1 Check-in
- Use of alcohol-, grapefruit-, or caffeine-containing foods or beverages within 72 hours prior to Period 1 Check-in
- Poor peripheral venous access
- Any acute or chronic condition that would limit the participant's ability to complete and/or participate in this clinical study
- Female participant is pregnant, lactating, or breastfeeding
- Use of PPIs or histamine H2 receptor antagonists within 1 month prior to Period 1 Check-in
- Known hypersensitivity to rabeprazole or any of its components or to derived products of benzimidazoles
- Predisposing factors to retinal vein occlusion (RVO)
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 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:Treatment A first, then Treatment B, followed by Treatment C
Treatment A in Period 1: One 20-mg tablet of cobimetinib will be administered orally with 240 milliliters (mL) room temperature water after at least an 8-hour fast.
Treatment B in Period 2: 20 mg oral rabeprazole will be administered once daily for 4 days starting on Day -4.
On Day 1, 20 mg rabeprazole will be administered in fasted state followed by one 20-mg tablet of cobimetinib administration orally with 240 mL room temperature water after at least an 8-hour fast.
Treatment C in Period 3: 20 mg oral rabeprazole will be administered once daily for 4 days starting on Day -4.
On Day 1, 20 mg rabeprazole will be administered in fasted state.
Approximately 30 minutes later, participants will be provided a standardized Food and Drug Administration (FDA) high-fat meal, and approximately 30 minutes after starting meal, one 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water.
There will be a 13-day washout between cobimetinib doses of each period.
|
One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast or approximately 30 minutes after starting the standardized FDA high-fat meal.
其他名称:
Rabeprazole 20 mg will be administered orally once daily for 4 days starting on Day -4 and on Day 1 of the treatment period.
|
|
实验性的:Treatment A first, then Treatment C, followed by Treatment B
Treatment A in Period 1: One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast.
Treatment C in Period 2: 20 mg oral rabeprazole will be administered once daily for 4 days starting on Day -4.
On Day 1 of the treatment period, 20 mg rabeprazole will be administered in fasted state.
Approximately 30 minutes later, participants will be provided a standardized FDA high-fat meal, and approximately 30 minutes after starting meal, one 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water.
Treatment B in Period 3: 20 mg oral rabeprazole will be administered once daily for 4 days starting on Day -4.
On Day 1 of treatment period, 20 mg rabeprazole will be administered in fasted state followed by one 20-mg tablet of cobimetinib administration orally with 240 mL room temperature water after at least an 8-hour fast.
There will be a 13-day washout between cobimetinib doses of each period.
|
One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast or approximately 30 minutes after starting the standardized FDA high-fat meal.
其他名称:
Rabeprazole 20 mg will be administered orally once daily for 4 days starting on Day -4 and on Day 1 of the treatment period.
|
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 |
|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Cobimetinib
大体时间:Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose
|
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf).
It is obtained from AUC (0 - t) plus AUC (t - inf).
|
Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose
|
|
Maximum Observed Concentration of Cobimetinib
大体时间:Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose
|
Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任:Isabelle Rooney, M.D., PhD、Genentech, Inc.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年1月1日
初级完成 (实际的)
2011年2月1日
研究完成 (实际的)
2011年2月1日
研究注册日期
首次提交
2011年1月7日
首先提交符合 QC 标准的
2011年1月13日
首次发布 (估计)
2011年1月17日
研究记录更新
最后更新发布 (实际的)
2017年5月10日
上次提交的符合 QC 标准的更新
2017年4月4日
最后验证
2017年4月1日
更多信息
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