NCT04987658已完成1 期
A Phase 1, Multiple-dose, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of OLZ/SAM in Pediatric Subjects (10-12 Years Old) With Bipolar I Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Time to reach maximum concentration
研究概览
简要总结
To evaluate the safety, tolerability, and pharmacokinetics of olanzapine and samidorphan in clinically stable pediatric subjects (10 to 12 years old) with Bipolar I disorder following oral administration of multiple ascending doses of OLZ/SAM
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 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject's parent(s)/legal guardian(s) is considered reliable by the Investigator and has agreed to provide support to the subject to ensure compliance with study treatment, visits, and protocol procedures.
- •Male and female subjects between 10 and 12 years of age, inclusive.
- •Subject weighs ≥70 pounds.
- •Subjects who are receiving antipsychotic treatment for their medical condition, with a diagnosis of bipolar I disorder.
- •Subjects must be considered stable, per investigator judgement.
- •Subject is willing to abide by the contraception requirements for the duration of the study.
排除标准
- •Subject has a comorbid neuropsychiatric disorder that could interfere with participation in the study.
- •Subject poses a current suicide risk as assessed by the Investigator or as confirmed by the baseline Columbia-Suicide Severity Rating Scale by a response of "Yes" to question numbers 4 or 5 with ideation or suicidal behavior occurring in the past 12 months (assessed at Screening and at Visit 2, Day 1).
- •Subject has a diagnosis of diabetes or presents with pre-diabetes lab results (hemoglobin A1c ≥6%).
- •Subject has a history of use of clozapine or use of long-acting injectable antipsychotic medication within 3 months prior to Screening.
- •Subject has a DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) diagnosis of moderate to severe alcohol disorder, or moderate to severe substance use disorder, within the 3 months prior to Screening.
- •Subject has taken opioid agonists within the 14 days prior to Screening, or has taken long-acting opioid agonist within the 30 days prior to Screening, or has anticipated a need to take opioid medication during the study period (eg, planned surgery, including oral surgery), or has taken opioid antagonists including naltrexone (any formulation) and naloxone within 60 days prior to Screening.
- •Subject is unable to swallow oral medications, as assessed by the Investigator.
- •Subject has a positive urine drug screen for opioids (assessed at Screening and at Visit 2, Day 1).
- •Subject has a positive cotinine test (assessed at Screening and at Visit 2, Day 1).
- •Subject has an intellectual disability, as assessed by the Investigator.
- •Subject has a history of intolerance or hypersensitivity to olanzapine or opioid antagonists, or any component of the study drug.
研究组 & 干预措施
Group 1 Olanzapine/ 5 mg Samidorphan
Experimental
Olanzapine will be gradually increased to a target dose of 10mg/samidorphan 5mg (Range: 5-20mg Olanzapine/samidorphan 5mg)
干预措施: OLZ/SAM (Drug)
Group 2 Olanzapine/ 10mg Samidorphan
Experimental
Olanzapine will be gradually increased to a target dose of 10mg/samidorphan 10mg (Range: 5-20mg Olanzapine/samidorphan 10mg)
干预措施: OLZ/SAM (Drug)
结局指标
主要结局
Time to reach maximum concentration
时间窗: Up to 3 weeks
Maximum plasma concentration observed
时间窗: Up to 3 weeks
Area under the plasma concentration-time curve over the 24-hour dosing interval
时间窗: Up to 3 weeks
Incidence of Adverse Events
时间窗: Up to 6 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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