NCT02804568已完成1 期
A Multiple-dose, Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALKS 3831 in Adult Subjects With Schizophrenia
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
- 42
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration (Cmax)
研究概览
简要总结
This study will determine the safety, tolerability, and pharmacokinetics (PK) of olanzapine and samidorphan in adults with schizophrenia following 14 consecutive days of oral administration of ALKS 3831.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Has a body mass index (BMI) of 18.0-35.0 kg/m^2, inclusive
- •Has a primary diagnosis of schizophrenia
- •Capable of understanding and complying with the procedures, requirements, and restrictions of the protocol.
- •Appropriate for outpatient treatment
- •Agrees to abide by the contraception requirements specified in the protocol for the duration of the study or is surgically sterile
- •Willing and able to provide government-issued identification
- •Is in good physical health
- •Agrees to maintain normal tobacco use as well as normal activities/exercise throughout the study
- •Additional criteria may apply
排除标准
- •Is currently pregnant or breastfeeding
- •Initiated first antipsychotic treatment within the past 12 months, or <1 year has elapsed since the initial onset of active-phase schizophrenia symptoms
- •Poses a current suicide risk at Visits 1 or 2
- •Has a history of poor or inadequate response to treatment with olanzapine
- •Has used a long-acting injectable antipsychotic medication in the last 6 months with the exception of 3-month paliperidone, which must not have been received within the past 12 months.
- •Requires or has had electroconvulsive therapy (ECT) treatment in the 6-month period prior to Visit 1
- •Has a diagnosis of alcohol or drug use disorder (with the exception of nicotine)
- •Has taken opioid agonists (codeine, oxycodone, tramadol, or morphine) within the 14 days prior to Visit 1 and/or anticipates a need to take opioid medication during the study period.
- •Has taken opioid antagonists including naltrexone (any formulations) and naloxone within 60 days prior to Visit 1, or has used any extended-release formulation of an opioid antagonist within 2 months prior to screening
- •Tests positive for amphetamines/methamphetamine, cocaine, barbiturates, opioids (codeine, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and buprenorphine), phencyclidine and benzodiazepines.
- •Has a known or suspected intolerance, allergy or hypersensitivity to olanzapine or opioid antagonists.
- •Additional criteria may apply
研究组 & 干预措施
Group 1
Experimental
Olanzapine/samidorphan 10 mg/10 mg
干预措施: ALKS 3831 (Drug)
Group 2
Experimental
Olanzapine/samidorphan 20 mg/10 mg
干预措施: ALKS 3831 (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax)
时间窗: Up to 15 days of dosing
Area under the concentration vs time curve over the 24 hour dosing interval (AUC0-24h)
时间窗: Up to 15 days of dosing
次要结局
- Safety will be determined by incidence of drug-related adverse events(Up to 21 days)
研究者
研究点 (1)
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