A Phase 1, Open-label Study to Evaluate the Effect of AG-881 on the Pharmacokinetics of a Single Dose of Lamotrigine in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Area under the Concentration-time Curve from Time 0 to Infinity (AUC0-inf) for Lamotrigine Administered with Interacting Drug AG-881
研究概览
简要总结
The main purpose of this study is to examine the effect of multiple doses of AG-881 on the pharmacokinetics (PK) of a single dose of lamotrigine in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
AG-881 (Group 1)
On Day 1 of Period 1, Group 1 participants will receive a single 50-milligram (mg) oral dose of lamotrigine at Hour 0. In Period 2, they will receive 50-mg oral doses of AG-881 once daily (QD) for 15 consecutive days (Days 1 to 15), with a single 50-mg oral dose of lamotrigine coadministered at Hour 0 on Day 14.
干预措施: Lamotrigine (Drug)
AG-881 (Group 1)
On Day 1 of Period 1, Group 1 participants will receive a single 50-milligram (mg) oral dose of lamotrigine at Hour 0. In Period 2, they will receive 50-mg oral doses of AG-881 once daily (QD) for 15 consecutive days (Days 1 to 15), with a single 50-mg oral dose of lamotrigine coadministered at Hour 0 on Day 14.
干预措施: AG-881 (Drug)
AG-881 (Group 2)
Following a safety and tolerability review of the data from at least 7 days of AG-881 dosing of Group 1 participants in Period 2, Group 2 participants will receive a single 50-mg oral dose of lamotrigine at Hour 0 in Period 1, and 50-mg oral doses of AG-881 QD for 15 consecutive days (Days 1 to 15), with a single 50-mg oral dose of lamotrigine coadministered at Hour 0 on Day 14 in Period 2.
干预措施: AG-881 (Drug)
AG-881 (Group 2)
Following a safety and tolerability review of the data from at least 7 days of AG-881 dosing of Group 1 participants in Period 2, Group 2 participants will receive a single 50-mg oral dose of lamotrigine at Hour 0 in Period 1, and 50-mg oral doses of AG-881 QD for 15 consecutive days (Days 1 to 15), with a single 50-mg oral dose of lamotrigine coadministered at Hour 0 on Day 14 in Period 2.
干预措施: Lamotrigine (Drug)
AG-881 (Group 3)
Following a safety and tolerability review of the data from Group 1 participants, and from at least 7 days of AG-881 dosing of Group 2 participants in Period 2, Group 3 participants will receive a single 50-mg oral dose of lamotrigine at Hour 0 in Period 1; and 50-mg oral doses of AG-881 QD for 15 consecutive days (Days 1 to 15) with a single 50-mg oral dose of lamotrigine coadministered at Hour 0 on Day 14 in Period 2.
干预措施: AG-881 (Drug)
AG-881 (Group 3)
Following a safety and tolerability review of the data from Group 1 participants, and from at least 7 days of AG-881 dosing of Group 2 participants in Period 2, Group 3 participants will receive a single 50-mg oral dose of lamotrigine at Hour 0 in Period 1; and 50-mg oral doses of AG-881 QD for 15 consecutive days (Days 1 to 15) with a single 50-mg oral dose of lamotrigine coadministered at Hour 0 on Day 14 in Period 2.
干预措施: Lamotrigine (Drug)
结局指标
主要结局
Area under the Concentration-time Curve from Time 0 to Infinity (AUC0-inf) for Lamotrigine Administered with Interacting Drug AG-881
时间窗: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Area under the Concentration-time Curve from Time 0 to Infinity (AUC0-inf) for Lamotrigine Administered without Interacting Drug AG-881
时间窗: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Maximum Observed Plasma Concentration (Cmax) for Lamotrigine Administered with Interacting Drug AG-881
时间窗: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Maximum Observed Plasma Concentration (Cmax) for Lamotrigine Administered without Interacting Drug AG-881
时间窗: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Area under the Concentration-time Curve, from Time 0 to the Last Observed Non-zero Concentration (t) (AUC0-t) for Lamotrigine Administered with Interacting Drug AG-881
时间窗: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Area under the Concentration-time Curve, from Time 0 to the Last Observed Non-zero Concentration (t) (AUC0-t) for Lamotrigine Administered without Interacting Drug AG-881
时间窗: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Percent of AUC0-inf Extrapolated (AUC%extrap) for Lamotrigine Administered with Interacting Drug AG-881
时间窗: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Percent of AUC0-inf Extrapolated (AUC%extrap) for Lamotrigine Administered without Interacting Drug AG-881
时间窗: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Time to Maximum Observed Plasma Concentration (Tmax) for Lamotrigine Administered with Interacting Drug AG-881
时间窗: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Time to Maximum Observed Plasma Concentration (Tmax) for Lamotrigine Administered without Interacting Drug AG-881
时间窗: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Apparent Terminal Elimination Rate Constant (Kel) for Lamotrigine Administered with Interacting Drug AG-881
时间窗: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Apparent Terminal Elimination Rate Constant (Kel) for Lamotrigine Administered without Interacting Drug AG-881
时间窗: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Apparent Terminal Elimination Half-life (t½) for Lamotrigine Administered with Interacting Drug AG-881
时间窗: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Apparent Terminal Elimination Half-life (t½) for Lamotrigine Administered without Interacting Drug AG-881
时间窗: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Apparent Total Plasma Clearance after Oral (Extravascular) Administration (CL/F) for Lamotrigine Administered with Interacting Drug AG-881
时间窗: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Apparent Total Plasma Clearance after Oral (Extravascular) Administration (CL/F) for Lamotrigine Administered without Interacting Drug AG-881
时间窗: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Apparent Volume of Distribution during the Terminal Elimination Phase after Oral (Extravascular) Administration (Vz/F) for Lamotrigine Administered with Interacting Drug AG-881
时间窗: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Apparent Volume of Distribution during the Terminal Elimination Phase after Oral (Extravascular) Administration (Vz/F) for Lamotrigine Administered without Interacting Drug AG-881
时间窗: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
次要结局
- Percentage of Participants with Adverse Events (AEs)(Up to approximately 4 weeks)
- Columbia-suicide Severity Rating Scale (C-SSRS)(Up to approximately 4 weeks)
- Percentage of Participants with Abnormalities in 12-lead Electrocardiograms (ECGs)(Up to approximately 4 weeks)
- Percentage of Participants with Abnormalities in Vital Sign Measurements(Up to approximately 4 weeks)
- Percentage of Participants with Abnormalities in Clinical Laboratory Tests(Up to approximately 4 weeks)
- Percentage of Participants with Abnormalities in Physical Examinations(Up to approximately 4 weeks)