NCT03480243已完成1 期
An Open-label, Fixed-sequence Study in Healthy Study Participants to Evaluate the Effect of Coadministered Erythromycin on the Pharmacokinetics and Safety of Padsevonil
UCB Biopharma S.P.R.L.1 个研究点 分布在 1 个国家实际入组 28 人开始时间: 2018年3月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours (AUC(0-12)) of Padsevonil for Single Dose
研究概览
简要总结
The purpose of this study is to evaluate and compare the Pharmacokinetics (PK) of concomitant administration of Padsevonil (PSL) in the presence and absence of erythromycin in healthy study participants.
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 序贯
- 主要目的
- 基础科学
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- Study participant is male or female and between 18 and 55 years of age (inclusive)
- Study participant is of a body weight of at least 50 kg for males and 45 kg for females, as determined by a body mass index (BMI) between 18 and 30 kg/m^2
- Female study participants use an efficient form of contraception for the duration of the study (unless menopausal). Hormonal contraception may be susceptible to an interaction with the Investigational Medicinal Product (IMP), which may reduce the efficacy of the contraception method. The potential for reduced efficacy of any hormonal contraception methods requires that a barrier method (preferably male condom) also be used
- Study participant has clinical laboratory test results within the local reference ranges or values are considered as not clinically relevant by the investigator and approved by the UCB Study Physician
- Study participant has Blood Pressure (BP) and pulse rate within normal range in supine position after 10 minutes of rest
- Male study participant agrees that, during the study period, when having sexual intercourse with a woman of childbearing potential, he will use an efficient barrier contraceptive (condom plus spermicide) AND that the respective partner will use an additional efficient contraceptive method
排除标准
- Study participant has previously received Investigational Medicinal Product (IMP) in this study
- Study participant has participated in another study of an IMP (or a medical device) within the previous 3 months before Screening (or within 5 half-lives for the IMP, whichever is longer) or is currently participating in another study of an IMP (or a medical device)
- Study participant has a history of drug or alcohol dependency within the previous 6 months or tests positive for alcohol (breath test) and/or drugs of abuse (urine test) at the Screening Visit or at any time during confinement
- Study participant has made a blood or plasma donation or has had a comparable blood loss (>400 mL) within the last 3 months prior to the Screening Visit
- Study participant smokes more than 5 cigarettes per day (or equivalent) or has done so within 6 months prior to the Screening Visit
- Study participant is taking any concomitant medication currently or within 2 weeks prior to the first day of dosing with the exception of paracetamol (acetaminophen)
- Study participant has any clinically relevant Electrocardiogram (ECG) finding at the Screening Visit or confinement
- Study participant has a history within the last 5 years or present condition of malignancy, with the exception of basal cell carcinoma
- Female study participant tests positive for pregnancy, plans to get pregnant during the participation in the study, or who is breastfeeding
研究组 & 干预措施
Padsevonil and Erythromycin
Experimental
Treatment Period 1 (Day 1 to Day 11):
- Padsevonil 100 mg twice daily (bid) on Day 1 to Day 4
- Padsevonil 100 mg single dose on Day 5
- 1 week of wash-out (from evening of Day 5 to Day 11)
Treatment Period 2 (Day 12 to 22):
- Padsevonil 100 mg twice daily (bid) on Day 12 to Day 15
- Padsevonil 100 mg single dose on Day 16
- 1 week of wash-out (from evening of Day 16 to Day 22)
Treatment Period 3 (Day 23 to Day 38):
- Erythromycin 500 mg twice daily (bid) on Day 23 to Day 25
- Padsevonil 100 mg bid and erythromycin 500 mg bid on Day 26 to Day 32
- Padsevonil 100 mg single dose on Day 33
- Erythromycin 500 mg twice daily (bid) on Day 33 to Day 36
- Erythromycin 500 mg single dose on Day 37
干预措施: Padsevonil (UCB0942) (Drug)
Padsevonil and Erythromycin
Experimental
Treatment Period 1 (Day 1 to Day 11):
- Padsevonil 100 mg twice daily (bid) on Day 1 to Day 4
- Padsevonil 100 mg single dose on Day 5
- 1 week of wash-out (from evening of Day 5 to Day 11)
Treatment Period 2 (Day 12 to 22):
- Padsevonil 100 mg twice daily (bid) on Day 12 to Day 15
- Padsevonil 100 mg single dose on Day 16
- 1 week of wash-out (from evening of Day 16 to Day 22)
Treatment Period 3 (Day 23 to Day 38):
- Erythromycin 500 mg twice daily (bid) on Day 23 to Day 25
- Padsevonil 100 mg bid and erythromycin 500 mg bid on Day 26 to Day 32
- Padsevonil 100 mg single dose on Day 33
- Erythromycin 500 mg twice daily (bid) on Day 33 to Day 36
- Erythromycin 500 mg single dose on Day 37
干预措施: Erythromycin (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours (AUC(0-12)) of Padsevonil for Single Dose
时间窗: Predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1, 12, and 26
AUC(0-12): The area under the plasma concentration-time curve from time zero to 12 hours of padsevonil for single dose . AUC(0-12) was expressed in hours times nanograms per milliliter (hours\*ng/mL).
Maximum Observed Steady-state Plasma Concentration (Cmax, ss) of Padsevonil for Multiple Doses
时间窗: Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3)
Cmax, ss: The maximum observed steady-state plasma concentration of padsevonil for multiple doses. Cmax, ss was expressed in nanograms per millilitre (ng/mL).
Area Under the Plasma Concentration-time Curve Over a Dosing Interval (12 Hours) (AUCtau) of Padsevonil for Multiple Doses
时间窗: Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3)
AUCtau: The area under the plasma concentration-time curve over a dosing interval (12 hours) of padsevonil for multiple doses. AUC(tau) was expressed in hours times nanograms per millilitre (hours\*ng/mL).
Maximum Observed Plasma Concentration (Cmax) of Padsevonil for Single Dose
时间窗: Predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1, 12, and 26
Cmax: The maximum observed plasma concentration of padsevonil for single dose . Cmax was expressed in nanograms per milliliter (ng/mL).
次要结局
- Time of Maximum Plasma Concentration (Tmax) of Padsevonil for Single Dose(Blood samples were taken at specific time points from pre-dose to 12 hours post first dose of Padsevonil for each Treatment Period)
- Minimum Observed Plasma Concentration (Cmin) of Padsevonil for Single Dose(Blood samples were taken at specific time points from pre-dose to 12 hours post first dose of Padsevonil for each Treatment Period)
- Time of Maximum Plasma Concentration (Tmax) of Padsevonil for Multiple Doses(Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3))
- Apparent Terminal Elimination Half-life at Steady-state (t1/2,ss) of Padsevonil for Multiple Doses in Plasma(Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3))
- Predose Observed Plasma Concentration (Ctrough) of Padsevonil for Multiple Doses(Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3))
- Apparent Total Clearance at Steady-state (CL/Fss) of Padsevonil for Multiple Doses in Plasma(Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3))
- Apparent Elimination Rate Constant (Lambdaz) of Padsevonil for Multiple Doses in Plasma(Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3))
- Maximum Observed Plasma Concentration (Cmax) of Padsevonil Metabolites (1 and 2) for Single Dose(Blood samples were taken at specific time points from pre-dose to 12 hours post first dose of Padsevonil for each Treatment Period)
- Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours (AUC(0-12)) of Padsevonil Metabolites (1 and 2) for Single Dose(Blood samples were taken at specific time points from pre-dose to 12 hours post first dose of Padsevonil for each Treatment Period)
- Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) During the Study(From beginning of the first Treatment Period (Day 1) to the Safety Follow-up Visit (up to 48 days ))
- Percentage of Participants Experiencing Treatment-Emergent Non-serious Adverse Events (AEs) During the Study(From beginning of the first Treatment Period (Day 1) to the Safety Follow-up Visit (up to 48 days ))
- Area Under the Plasma Concentration-time Curve Over a Dosing Interval (12 Hours) (AUCtau) of Padsevonil Metabolites (1 and 2) for Multiple Doses(Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3))
- Maximum Observed Steady-state Plasma Concentration (Cmax, ss) of Padsevonil Metabolites (1 and 2) for Multiple Doses(Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3))
- Metabolite-to-parent Ratio for Cmax of Padsevonil Metabolites (1 and 2) in Plasma(Blood samples were taken at specific time points from pre-dose to 12 hours post dose of Padsevonil for each Treatment Period)
- Metabolite-to-parent Ratio for AUC(0-12) of Padsevonil Metabolites (1 and 2) in Plasma(Blood samples were taken at specific time points from pre-dose to 12 hours post first dose of Padsevonil for each Treatment Period)
- Metabolite-to-parent Ratio for AUCtau of Padsevonil Metabolites (1 and 2) in Plasma(Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3))
- Renal Clearance (CLr) of Padsevonil and Metabolites (1 and 2) for Single Dose in Urine(Urine samples were taken 0 to 12 hours post first dose of Padsevonil during each Treatment Period)
- Renal Clearance (CLr) of Padsevonil and Metabolites (1 and 2) for Multiple Doses in Urine(Urine samples were taken 0 to 12 hours, 12 to 24 hours,and 24 to 48 hours post last PSL dose during Treatment Period 1 and 2; 0 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 to 72 hours, and 72 to 96 hours post last dose of PSL during Treatment Period 3)
- Cumulative Amount (Ae) of Padsevonil and Metabolites (1, 2, and 3) Excreted Into the Urine for Single Dose(Urine samples were taken 0 to 12 hours post first dose of Padsevonil during each Treatment Period)
- Cumulative Amount (Ae) of Padsevonil and Metabolites (1, 2, and 3) Excreted Into the Urine for Multiple Doses(Urine samples were taken 0 to 12 hours, 12 to 24 hours,and 24 to 48 hours post last PSL dose during Treatment Period 1 and 2; 0 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 to 72 hours, and 72 to 96 hours post last dose of PSL during Treatment Period 3)
- Fraction (fe) of Padsevonil and Metabolites (1, 2, and 3) Excreted Into the Urine for Single Dose(Urine samples were taken 0 to 12 hours post first dose of Padsevonil during each Treatment Period)
- Fraction (fe) of Padsevonil and Metabolites (1, 2, and 3) Excreted Into the Urine for Multiple Doses(Urine samples were taken 0 to 12 hours, 12 to 24 hours,and 24 to 48 hours post last PSL dose during Treatment Period 1 and 2; 0 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 to 72 hours, and 72 to 96 hours post last dose of PSL during Treatment Period 3)
- Formation Clearance (CLform) of Padsevonil Metabolites (1, 2, and 3) in the Urine for Single Dose(Urine samples were taken 0 to 12 hours post first dose of Padsevonil during each Treatment Period)
- Formation Clearance (CLform) of Padsevonil Metabolites (1, 2, and 3) in the Urine for Multiple Doses(Urine samples were taken 0 to 12 hours, 12 to 24 hours,and 24 to 48 hours post last PSL dose during Treatment Period 1 and 2; 0 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 to 72 hours, and 72 to 96 hours post last dose of PSL during Treatment Period 3)
研究者
研究点 (1)
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标识符
- NCT 编号
- NCT03480243
- 其他研究编号
- UP0057, 2017-004694-13
日期
- 首次提交
- (8年前)
- 首次发布
- (8年前)
- 主要完成日期
- (8年前)
- 研究完成日期
- (8年前)
- 最近核实
- 最近更新
- (5年前)
监管与共享
- FDA 监管药物
- 否
- 是否有结果
- 是
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