Phase 1 Oral Solution Bioavailability Study of Apixaban When Administered Through a Nasogastric Tube in Healthy Subjects
2016年6月9日 更新者:Bristol-Myers Squibb
Study of Apixaban Oral Solution Bioavailability When Administered Through a Nasogastric Tube in Healthy Subjects
The purpose of this study is to assess the bioavailability of Apixaban solution administered through NGT and washed with Dextrose 5% in water (D5W) or infant formula relative to Apixaban solution administered orally in healthy subjects
研究概览
研究类型
介入性
注册 (实际的)
75
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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Maryland
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Baltimore、Maryland、美国、21225
- Parexel Baltimore Early Phase Clinical Unit
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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 45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:
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
Exclusion Criteria:
- Any significant acute or chronic medical illness
- Any history or evidence of abnormal bleeding or coagulation disorders, intracranial hemorrhage, or abnormal bleeding (including heavy menstrual bleeding that has resulted in anemia within the past 1 year) or coagulation disorders in a first degree relative
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:基础科学
- 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:Arm A: Apixaban
Single dose Apixaban 5 mg (0.4 mg/mL x 12.5 mL) oral solution via oral syringe
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其他名称:
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实验性的:Arm B: Apixaban
Single dose Apixaban 5 mg (0.4 mg/mL x 12.5 mL) oral solution via nasogastric tube (NGT) immediately followed by 60 mL of D5W via NGT
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其他名称:
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实验性的:Arm C: Apixaban
Single dose Apixaban 5 mg (0.4 mg/mL x 12.5 mL) oral solution via NGT immediately followed by 60 mL of infant formula via NGT
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其他名称:
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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 |
---|---|---|
Adjusted Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Apixaban
大体时间:Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3
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Samples of plasma from participants were obtained at the following times: 0 hour (h) and post dose at 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h.
Apixaban was assayed using a validated Liquid chromatography tandem mass spectrometry (LC-MS/MS) method during the period of known analyte stability.
Maximum observed plasma concentration (Cmax) was measured in nanograms per milliliter (ng/mL).
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Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Death
大体时间:Day 1 to Day 12
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AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
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Day 1 to Day 12
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Median Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban
大体时间:Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3
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Samples of plasma from participants were obtained at the following times: 0 hour (h), 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period.
Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability.
Maximum observed plasma concentration (Tmax) was measured in hours (h).
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Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3
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Adjusted Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of Last Quantifiable Plasma Concentration, AUC(0-T), of Apixaban
大体时间:Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3
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Samples of plasma from participants were obtained at the following times: 0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period.
Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability.
AUC(0-T) was measured in nanograms*hours per milliliter (ng*h/mL).
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Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3
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Adjusted Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time, AUC(INF), of Apixaban
大体时间:Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3
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Samples of plasma from participants were obtained at the following times: 0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period.
Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability.
AUC(0-INF) was measured in ng*h/mL.
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Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3
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Mean Plasma Elimination Half-Life (T-HALF) of Apixaban
大体时间:Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3
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Samples of plasma from participants were obtained at the following times: 0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period.
Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability.
T-HALF was measured in hours (h).
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Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3
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Number of Participants With Clinically Significant Electrocardiogram, Vital Sign, or Physical Examination Findings
大体时间:Screening, Day 1 of Periods, 1, 2, and 3, and Day 4 of Period 3
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12-lead electrocardiograms (ECGs) and Vital Signs were performed at Screening, and Day 1 of Periods 1, 2 and 3 (pre-dose and prior to NGT placement, if done).
Vital signs and ECGs were also performed on Day 4 of Period 3, prior to discharge from the study.
Vital signs included body temperature, respiratory rate, seated blood pressure and heart rate.
Blood pressure and heart rate were measured after the participant had been seated quietly for at least 5 minutes.
Participants had physical examinations on Period 1, Day 1 (pre-dose) and Day 4 of Period 3, prior to study discharge.
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Screening, Day 1 of Periods, 1, 2, and 3, and Day 4 of Period 3
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Number of Participants With Marked Abnormality in Hematology, Chemistry and Urinalysis Laboratory Tests
大体时间:Screening, Day -1, Day 4 of Periods, 1, 2, and 3
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Participants were required to fast for at least 10 hours prior to the collection of specimens for clinical laboratory tests.
Tests were performed at Screening, Day -1, and Day 4 of each period 1 - 3. Leukocyte criteria: Lower limits of normal (LLN), upper limits of normal (ULN), pre-treatment (preRX).
Low Leukocytes: if value < 0.9*LLN, or if preRX < LLN then use < 0.85* preRX.
High lymphocytes: if value > 7.500 10^3 cells/ µL.
Low neutrophils plus bands: if value <= 1.500 10^3 cells/µL.
High creatine kinase: if value > 1.5* ULN.
Blood in urine: if value >= 2 plus, or if preRX >= 1 plus then use >= 2*preRX.
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Screening, Day -1, Day 4 of Periods, 1, 2, and 3
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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。
合作者
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
2011年7月1日
初级完成 (实际的)
2011年8月1日
研究完成 (实际的)
2011年8月1日
研究注册日期
首次提交
2014年1月10日
首先提交符合 QC 标准的
2014年1月10日
首次发布 (估计)
2014年1月13日
研究记录更新
最后更新发布 (估计)
2016年7月20日
上次提交的符合 QC 标准的更新
2016年6月9日
最后验证
2016年6月1日
更多信息
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