A Multicenter, Open-label, Sequential Cohort, Dose-escalation, 14-day Study to Explore the Tolerability and Pharmacokinetics of Iloperidone 12 to 24 mg/Day Followed by 26 Weeks of Flexible Dosing (6 to 24 mg/Day) in Adolescent Patients (Aged 12 to 17 Years)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of iloperidone at different dose levels based on AUC (area under the plasma concentration time curve during a dosage interval) Cmax ss (maximum plasma concentration at steady state), Tmax ss (time to Cmax at steady state).
研究概览
简要总结
Tolerability, undertstanding of the action of the drug in the body, and understanding the effect of the drug in adolescent patients needing treatment with an antipsychotic medication
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males or females 12-17 years of age.
- •in a stable housing situation with a guardian/parent who can encourage compliance with the study protocol.
- •with diagnosis of disorder requiring treatment with an antipsychotic agent.
- •having a Children's Global Assessment of Severity Scale (CGAS) of 41 or greater.
- •Heart rate </=100 beats per minute and >/= 50 beats per minute.
排除标准
- •Patients with mild, moderate or severe mental retardation (i.e., documented IQ <70), do not have the capacity to assent, cannot understand the informed consent, or participate fully in the assessments.
- •Hospitalized due to suicidal ideation or suicidal behavior, history of suicidal ideation within 6 months prior to screening, history of suicidal behavior within 2 years prior to screening.
- •Pregnant, females who can become pregnant and lactating females.
- •Known hypersensitivity to iloperidone and to related drugs.
- •Clinical conditions (Neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal or urological), which may pose significant risk to patients or impair reliable study participation.
- •Clinically unstable cardiac disease, structural cardiac abnormalities, congential long QT syndrome, clinically significant ECG abnormalities at screening (PR interval >240 ms, QTcF >450 ms, QRS duration >/= 100 ms) or arrhythmias.
- •Syncope, near syncope, or palpitations. Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Iloperidone
Part A (dose-escalation and fixed dose): Eligible patients receive iloperidone 2mg/day (1 mg BID) on day 1, then escalated every day for up to 12days utilizing a forced titration regimen to achieve a maximum dose of 12, 16, 20 or 24 mg/day given BID. Part B (optional extension phase): Patients who successfully complete Part A of the study are eligible to continue treatment with iloperidone for an additional 26 weeks
干预措施: iloperidone (oral tablet) (Drug)
结局指标
主要结局
Pharmacokinetics of iloperidone at different dose levels based on AUC (area under the plasma concentration time curve during a dosage interval) Cmax ss (maximum plasma concentration at steady state), Tmax ss (time to Cmax at steady state).
时间窗: Visit 5, 6, 7 (after at least 7 days of iloperidone treatment at the same dose level)
Pharmacokinetics describes the action of a drug in the body over a period of time. Blood samples are collected to measure plasma concentrations of the study drug at different times after dosing. From the plasma concentration data, AUC, Cmax ss, and Tmax ss are calculated.
Tolerability of iloperidone at different dose levels
时间窗: 14 days
Frequency of treatment emergent adverse events, frequency of clinically notable changes from baseline in vital signs, electrocardiograms, laboratory tests, and reponses on movement disorder rating scales (Barnes Akathisia Rating Scale, Simpson-Angus Scale) and on a rating scale for suicidal thoughts and behaviors (Columbia Suicide Severity Rating Scale)
次要结局
- Change from baseline in the Children's Global Asessment Scale (CGAS(Baseline, then Weekly for 2 weeks, then every 2-4 weeks for 26 weeks)
- Clinically notable changes from baseline on electrocardiogram (ECG) parameters (QTcF, QTcB, QRS, PR, heart rate)(Screening, baseline, 5x over 2 weeks, then every 2-4 weeks for 26 weeks)
- Number of Patients with Adverse Events, Serious Adverse Events or Death(26 weeks)
- Effect of iloperidone on QT, QT beat-to-beat (QTbtb), QT corrected using the Fridericia formulat (QTcF), QT corrected using the Bazett formula (QTcB), individual based correct QT (QTcI)(Baseline (24 hours), Visit 3 (4-hours post initial dose), and Visit 7 (13 hours)
- Change from baseline in Clinical Global Impression of Improvement Scale (CGI-I)(Baseline, then Weekly for 2 weeks, then every 2-4 weeks for 26 weeks)