A Study to Test the Safety, and Tolerability of Padsevonil in Healthy Male Japanese Study Participants
2021年6月16日 更新者:UCB Biopharma S.P.R.L.
An Open-Label, Parallel Group, Single-Center Study to Investigate the Pharmacokinetic, Safety, and Tolerability Profiles of Padsevonil in CYP2C19 Genotyped Healthy Male Japanese Study Participants
The purpose of the study is to investigate the pharmacokinetics (PK) of padesevonil in CYP2C19 genotyped healthy male Japanese study participants.
研究概览
研究类型
介入性
注册 (实际的)
39
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
-
-
-
Tokyo、日本
- Up0083 001
-
-
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
20年 至 55年 (成人)
接受健康志愿者
不
有资格学习的性别
男性
描述
Inclusion Criteria:
- The study participant must be 20 to 55 years of age inclusive, at the time of signing the informed consent
- The study participant is overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
- The study participant is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage
- The study participant has a body weight ≥50 kg and body mass index within the range [18 to 30] kg/m^2 (inclusive)
- The study participant is male
Exclusion Criteria:
- The study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study, such as a history of schizophrenia, or other psychotic disorder, bipolar disorder, or severe unipolar depression. The presence of potential psychiatric exclusion criteria will be determined based on the psychiatric history collected at the Screening Visit
- The study participant has a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders, capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data
- The study participant has a history of unexplained syncope or a family history of sudden death due to long QT syndrome
- The study participant has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has had suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Screening/Baseline" version of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening
- The study participant has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) >1.0 x upper limit of normal (ULN)
- The study participant has bilirubin >1.0 x ULN (isolated bilirubin >1.0 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 %)
- The study participant has current or chronic history of liver disease or known hepatic or biliary abnormalities
- The study participant has any clinically relevant electrocardiogram (ECG) finding at the Screening Visit or at Baseline.
- The study participant has made a blood or plasma donation or has had a comparable blood loss (>450 mL) within the last 30 days prior to Screening. Blood donation during the study is not permitted
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:非随机化
- 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:Extensive metabolizers
Participants will receive assigned single and multiple doses of padsevonil.
|
Padsevonil 将以预先确定的剂量给药。
|
|
实验性的:Intermediate metabolizers
Participants will receive assigned single and multiple doses of padsevonil.
|
Padsevonil 将以预先确定的剂量给药。
|
|
实验性的:Poor metabolizers
Participants will receive assigned single and multiple doses of padsevonil.
|
Padsevonil 将以预先确定的剂量给药。
|
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 Plasma Concentration (Cmax) of a Single Dose Padsevonil
大体时间:Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
|
Cmax is the maximum plasma drug concentration of PSL observed from pharmacokinetic samples taken at predefined time points.
|
Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
|
|
Area Under the Curve From 0 to t (AUC(0-t)) of a Single Dose Padsevonil
大体时间:Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
|
AUC(0-t) is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration.
|
Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
|
|
Area Under the Curve From Time 0 to Infinity (AUC) of a Single Dose Padsevonil
大体时间:Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
|
AUC is the area under the plasma concentration-time curve from time zero to infinity.
|
Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
|
|
Terminal Half-life (t1/2) of a Single Dose Padsevonil
大体时间:Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
|
The t1/2 is the apparent terminal half-life.
Geometric Means and Geometric Coefficient of Variations were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e.
non-calculated and non-flagged).
|
Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
|
|
Time to Reach the Maximum Plasma Concentration (Tmax) of a Single Dose Padsevonil
大体时间:Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
|
The tmax is the time to reach maximum plasma concentration.
|
Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
|
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Maximum Plasma Concentration (Cmax) of Padsevonil at Steady-state (ss)
大体时间:Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose
|
Cmax, ss is the maximum plasma concentration of PSL observed from pharmacokinetic samples, taken at predefined time point at a steady-state.
|
Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose
|
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Area Under the Curve Over a Dosing Interval (AUCtau) of Multiple Doses Padsevonil
大体时间:Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose
|
AUCtau is the area under the plasma concentration time curve over a dosing interval.
|
Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose
|
|
Terminal Half-life (t1/2) of Multiple Doses Padsevonil
大体时间:Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose
|
The t1/2 is the apparent terminal half-life.
|
Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose
|
|
Time to Reach Maximum Concentration (Tmax) for Padsevonil at Steady-state (ss)
大体时间:Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose
|
The tmax, ss is the time of observed maximum plasma concentration at a steady-state.
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Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose
|
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Percentage of Participants With Treatment Emergent Adverse Events During the Study
大体时间:From Baseline until the Safety Follow-up Visit (up to Day 21)
|
An Adverse Event (AE) is any untoward medical occurrence in a participant or trial participant that is administered a drug or biologic (medicinal product) or that is using a medical device.
The event does not necessarily have a causal relationship with that treatment or usage.
|
From Baseline until the Safety Follow-up Visit (up to Day 21)
|
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 (实际的)
2019年9月30日
初级完成 (实际的)
2019年12月27日
研究完成 (实际的)
2019年12月27日
研究注册日期
首次提交
2019年8月29日
首先提交符合 QC 标准的
2019年8月29日
首次发布 (实际的)
2019年8月30日
研究记录更新
最后更新发布 (实际的)
2021年7月8日
上次提交的符合 QC 标准的更新
2021年6月16日
最后验证
2021年6月1日
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)?
不
IPD 计划说明
Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified.
For this reason, data from this trial cannot be shared.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.