A Sequential Groups, Open Label, Rising Multiple Dose Study to Assess the Pharmacokinetics, Safety and Tolerability of Sublingual Asenapine in a Pediatric Population With Schizophrenia or Bipolar I Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Maximum Plasma Concentration (Cmax) of Asenapine
研究概览
简要总结
This study is an open label, sequential-group, two site, multiple dose escalating study of sublingual administered asenapine in a pediatric population with schizophrenia or bipolar I disorder; in one study cohort (3a) participants with other conditions treatable with chronic antipsychotic medication can also be enrolled. Participants will receive a single sublingual placebo dose on Day -1, followed by multiple sublingual doses of asenapine twice daily (b.i.d.) for 6 days (Cohorts 1 and 2), 7 days (Cohort 3b-d), or 11 days (Cohort 3a), and a final once daily administration on Day 7 (Cohorts 1 and 2), Day 8 (Cohort 3b-d) or Day 12 (Cohort 3a).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1
Participants 10 or 11 years of age
干预措施: Asenapine 2.5 mg (Drug)
Cohort 2
Participants 10 or 11 years of age
干预措施: Asenapine 5 mg (Drug)
Cohort 3a-d
Cohort 3a: Participants 10 or 11 years of age
Cohort 3b: Participants 12 or 13 years of age
Cohort 3c: Participants 14 or 15 years of age
Cohort 3d: Participants 16 or 17 years of age
干预措施: Asenapine 10 mg (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of Asenapine
时间窗: Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36 and 48 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)
Cmax is the peak plasma concentration following a dose of the study drug.
Time to Maximum Plasma Concentration (Tmax) of Asenapine
时间窗: Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36 and 48 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)
tmax is the time from dosing to maximum plasma drug concentration levels.
Area Under the Plasma Concentration-time Curve From 0 to 12 Hours Post Dose (AUC0-12) of Asenapine
时间窗: Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6 and 12 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)
AUC0-12 is the area under the plasma drug-concentration time curve calculated for the 12 hour interval after dosing.
Terminal Phase (Elimination) Half-life (t1/2) of Asenapine
时间窗: Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36 and 48 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)
Elimination t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase.
次要结局
未报告次要终点