A Study to Assess the Relative Bioavailability Between Two ASP015K Tablets and the Food Effect of a New Tablet in Healthy Adult Subjects
2013年9月13日 更新者:Astellas Pharma Global Development, Inc.
A Phase 1, Single-Dose, Open-Label, 3-Period, Randomized Crossover Study to Assess the Relative Bioavailability Between Two ASP015K Tablet Formulations and the Food Effect on a New Tablet Formulation in Healthy Adult Subjects
The purpose of this study is to determine the relative bioavailability of ASP015K under fasting conditions after single-dose administration between a test-tablet formulation and a reference-tablet formulation.
This study will also evaluate the food effect on bioavailability of the test formulation, and evaluate the safety and tolerability after single-dose administration of the test- and reference-tablet formulations.
研究概览
研究类型
介入性
注册 (实际的)
36
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
-
-
Maryland
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Baltimore、Maryland、美国、21225
- Parexel - Early Phase Clinical Unit
-
-
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:
- Female subject must be of non-childbearing potential (i.e., post-menopausal [defined as at least 1 year without menses prior to screening], or documented surgically sterile or status post hysterectomy [at least 1 month prior to screening]).
- Female subject must have a negative pregnancy test at screening and day -1 of treatment period 1.
- Female subject must not donate ova starting at screening and throughout the study period, and for 90 days after the final study drug administration.
- Male subject and his female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at screening and continue throughout the study period and for 90 days after final study drug administration.
- Male subject must not donate sperm starting at screening and throughout the study period and for 90 days after final study drug administration.
- Subject has a Body Mass Index (BMI) range of 18.5-32.0 kg/m2, inclusive, and must weigh at least 50 kg at screening.
Exclusion Criteria:
- Female subject who has been pregnant within 6 months before screening assessment or breast feeding within 3 months before screening.
- Subject has a known or suspected hypersensitivity to ASP015K, or any components of the formulation used.
- Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to first clinic check-in.
- Subject has used any prescribed or non-prescribed drugs (including vitamins, natural and herbal remedies, e.g., St. John's Wort) in the 2 weeks prior to study drug administration, with the exception of hormone replacement therapy (HRT), intermittent acetaminophen (to a maximum of 2 g/day).
- Subject has smoked or has used tobacco-containing products and nicotine or nicotine-containing products in the past six months prior to screening.
- Subject has a history of consuming more than 14 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical substance abuse within past 2 years prior to screening (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits) prior to day -1 of treatment period 1.
- Subject has had any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic check-in on day -1 of treatment period 1.
- Subject has a positive test for hepatitis B surface antigen (HBsAg), anti-hepatitis A virus (HAV) (Immunoglobulin [Ig] M), anti-hepatitis C virus (HCV), hepatitis B core antibody, or anti-human immunodeficiency virus (HIV) type 1 or type 2 at screening.
- Subject has a positive tuberculosis (TB) skin test, Quantiferon Gold® test or T-SPOT® test at screening.
- Subject received any vaccine within 60 days prior to study drug administration.
- Subject has an absolute neutrophil count (ANC) < 2000 cells/mm3 or a creatine phosphokinase (CPK) > 1.5 x ULN at screening or day -1 of treatment period 1.
- Subject has had major gastrointestinal (GI) surgery or has a medical condition, which may inhibit the absorption and/or metabolism of study drug.
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
- 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:ASP015K Test Tablet - Fasting Conditions
ASP015K administered as a single tablet under fasting conditions.
|
oral tablet
|
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实验性的:ASP015K Reference Tablet - Fasting Conditions
ASP015K administered via multiple tablets under fasting conditions
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oral tablet
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实验性的:ASP015K Test Tablet -Fed Conditions
ASP015K administered as a single tablet under fed conditions
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oral tablet
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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 |
|---|---|---|
|
Pharmacokinetic parameter of ASP015K: Cmax
大体时间:Day 1-4 of each treatment period
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Maximum Concentration (Cmax)
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Day 1-4 of each treatment period
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Pharmacokinetic parameter of ASP015K: AUClast
大体时间:Day 1-4 of each treatment period
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Area Under the Curve from time zero to the last measurable time (AUClast)
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Day 1-4 of each treatment period
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Pharmacokinetic parameter of ASP015K: AUCinf
大体时间:Day 1-4 of each treatment period
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Area Under the Curve from time zero extrapolated to infinity (AUCinf)
|
Day 1-4 of each treatment period
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Composite of pharmacokinetic parameters of ASP015K: tmax, t1/2
大体时间:Day 1-4 of each treatment period
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Time to Maximum Concentration (tmax), apparent terminal elimination half-life (t1/2)
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Day 1-4 of each treatment period
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Composite of pharmacokinetic parameters of ASP015K metabolites: Cmax, AUClast, AUCinf, tmax, t1/2
大体时间:Day 1-4 of each treatment period
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Day 1-4 of each treatment period
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|
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Safety assessed by adverse events, clinical laboratory evaluations, 12-lead ECG measurements, physical examinations and vital sign measurements
大体时间:Up to Day 4 in each treatment period
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Up to Day 4 in each treatment period
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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。
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
2013年5月1日
初级完成 (实际的)
2013年8月1日
研究完成 (实际的)
2013年8月1日
研究注册日期
首次提交
2013年8月23日
首先提交符合 QC 标准的
2013年8月23日
首次发布 (估计)
2013年8月28日
研究记录更新
最后更新发布 (估计)
2013年9月16日
上次提交的符合 QC 标准的更新
2013年9月13日
最后验证
2013年9月1日
更多信息
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