A Study in Healthy Participants Evaluating the Absorption of a BMS-986205 Tablet Into the Bloodstream Compared to a Reference Tablet
2018年2月26日 更新者：Bristol-Myers Squibb
A Randomized, Open-Label Study to Evaluate the Bioavailability of a BMS-986205 Tablet Containing Free Base Relative to a Reference Tablet in Healthy Participants
This is a Phase 1, open-label, randomized study in healthy participants to evaluate the absorption of a BMS-986205 tablet into the bloodstream compared to a reference tablet.
Eligible participants will be randomly assigned to 1 of 2 treatment sequences and will receive a single, oral dose of BMS-986205 twice over 22 days.
Participants must remain at the clinical facility for the duration of the study.
研究概览
研究类型
介入性
注册 (实际的)
16
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Texas
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Austin、Texas、美国、78744
- PPD Austin Clinic
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-
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 50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:
- Signed, written informed consent.
- Healthy male and female participants (not of childbearing potential), determined by medical history, physical examination, electrocardiograms (ECGs) and clinical laboratory tests.
- Normal renal (kidney) function.
- Body Mass Index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive.
- Women must have documented proof they are not of childbearing potential.
- Males who are sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment and 110 days after the last dose of BMS-986205. In addition, male participants must be willing to refrain from sperm donation during this time.
Exclusion Criteria:
- Women of childbearing potential or breastfeeding.
- Active tuberculosis (TB) requiring treatment or documented latent TB within the previous 3 years. Also excluded are participants with evidence of a past TB infection without documented adequate therapy.
- History of pulmonary, renal, or liver disease; or of cardiac arrhythmias.
- Recent (within 6 months of study drug administration) history of smoking or current smokers. This includes participants using electronic cigarettes or nicotine-containing products such as tobacco for chewing, nicotine patches, nicotine lozenges or nicotine gum.
- Donation of blood to a blood bank or in a clinical study (except screening or follow-up visit) within 4 weeks of study drug administration (within 2 weeks for plasma only).
Other protocol defined inclusion/exclusion criteria could apply.
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：Reference tablet followed by BMS-986205 tablet with free base
BMS-986205 reference tablet (treatment period 1) followed by BMS-986205 tablet with free base (treatment period 2).
|
Single, 100 mg oral dose.
Single, 100 mg oral dose.
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|
实验性的：BMS-986205 tablet with free base followed by reference tablet
BMS-986205 tablet with free base (treatment period 1) followed by BMS-986205 reference tablet (treatment period 2).
|
Single, 100 mg oral dose.
Single, 100 mg oral dose.
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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 |
|---|---|---|
|
Maximum observed plasma concentration (Cmax) of BMS-986205 tablet with free base compared to reference tablet.
大体时间：Up to Day 22
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Measured by plasma concentration.
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Up to Day 22
|
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Area under the plasma concentration time curve from time zero to 168 hours after dosing (AUC[0-168]) of BMS-986205 tablet with free base compared to reference tablet.
大体时间：Up to Day 22
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Measured by plasma concentration.
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Up to Day 22
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of non-serious Adverse Events (AEs).
大体时间：Up to Day 22
|
Safety and tolerability as measured by incidence of non-serious AEs.
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Up to Day 22
|
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Incidence of Serious Adverse Events (SAEs).
大体时间：Up to Day 22
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Safety and tolerability as measured by incidence of SAEs.
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Up to Day 22
|
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Incidence of Adverse Events (AEs) leading to discontinuation.
大体时间：Up to Day 22
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Safety and tolerability as measured by incidence of AEs leading to discontinuation.
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Up to Day 22
|
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Number of participants with vital sign abnormalities.
大体时间：Up to Day 22
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Up to Day 22
|
|
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Number of participants with electrocardiogram (ECG) abnormalities.
大体时间：Up to Day 22
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Up to Day 22
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Number of participants with clinical laboratory abnormalities.
大体时间：Up to Day 22
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Up to Day 22
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Number of participants with physical examination abnormalities.
大体时间：Up to Day 22
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Up to Day 22
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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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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 (实际的)
2017年12月21日
初级完成 (实际的)
2018年2月15日
研究完成 (实际的)
2018年2月22日
研究注册日期
首次提交
2017年12月15日
首先提交符合 QC 标准的
2017年12月18日
首次发布 (实际的)
2017年12月19日
研究记录更新
最后更新发布 (实际的)
2018年2月28日
上次提交的符合 QC 标准的更新
2018年2月26日
最后验证
2018年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.