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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Area Under the Curve From 0 to t (AUC(0-t)) of a Single Dose Padsevonil
研究概览
简要总结
The purpose of the study is to investigate the pharmacokinetics (PK) of padesevonil in CYP2C19 genotyped healthy male Japanese study participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Extensive metabolizers
Participants will receive assigned single and multiple doses of padsevonil.
干预措施: Padsevonil (Drug)
Intermediate metabolizers
Participants will receive assigned single and multiple doses of padsevonil.
干预措施: Padsevonil (Drug)
Poor metabolizers
Participants will receive assigned single and multiple doses of padsevonil.
干预措施: Padsevonil (Drug)
结局指标
主要结局
Area Under the Curve From 0 to t (AUC(0-t)) of a Single Dose Padsevonil
时间窗: 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.
Percentage of Participants With Treatment Emergent Adverse Events During the Study
时间窗: 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.
Terminal Half-life (t1/2) of a Single Dose Padsevonil
时间窗: 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).
Time to Reach the Maximum Plasma Concentration (Tmax) of a Single Dose Padsevonil
时间窗: 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.
Area Under the Curve Over a Dosing Interval (AUCtau) of Multiple Doses Padsevonil
时间窗: 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.
Time to Reach Maximum Concentration (Tmax) for Padsevonil at Steady-state (ss)
时间窗: 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.
Maximum Plasma Concentration (Cmax) of a Single Dose Padsevonil
时间窗: 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.
Area Under the Curve From Time 0 to Infinity (AUC) of a Single Dose Padsevonil
时间窗: 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.
Maximum Plasma Concentration (Cmax) of Padsevonil at Steady-state (ss)
时间窗: 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.
Terminal Half-life (t1/2) of Multiple Doses Padsevonil
时间窗: 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.
次要结局
未报告次要终点