A Randomized, Open-Label, Single Dose, Cross-over Study of Gastric Emptying Rate: SEP-363856 vs Prior Antipsychotic Standard of Care in Subjects With Schizophrenia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 7
- 主要终点
- Gastric retention at 4 hr post-radiolabeled meal (gastric emptying scintigraphy (GES) imaging)
研究概览
简要总结
A clinical study to determine whether an investigational medication (SEP363856) changes how long it takes for food to move through the stomach into the small intestine in patients with schizophrenia. This study is accepting both male and female subjects. It will be conducted in approximately 6 study sites in the United States. The duration of participation will be approximtely 10 weeks.
详细描述
This is a randomized, open-label, single dose two-period crossover study with two treatment sequences. For each treatment sequence, subjects will receive a single-dose of SEP-363856 and prior antipsychotic (PA) standard of care (PA) in random order. Up to 3 separate cohorts of subjects will be randomized to determine the final dose of SEP-363856.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(this list is not all inclusive)
- •Male or female subjects between 18 and 65 years of age, inclusive at time of consent.
- •Subject meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a primary diagnosis of schizophrenia as established by clinical interview, using the DSM-5 as a reference and confirmed using the Structured Clinical Interview for DSM-5, Clinical Trials Version [SCID-CT]).
- •Subject must have a CGI-S score ≤ 4 (normal to moderately ill) at Screening
- •Subject must have a PANSS total score ≤ 80 at Screening and a score of ≤ 4 on the following PANSS items at Screening: P7 (hostility) and G8 (uncooperativeness)
- •Subjects' antipsychotic medication at screening must have had no dose change (minor dose adjustments for tolerability purposes are permitted) for at least eight weeks prior to the Screening visit.
排除标准
- •(this list is not all inclusive)
- •Subject has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia or intellectual disability (IQ < 70).
- •Subject has attempted suicide within 12 months prior to Screening.
- •Subject answers "yes" to "Suicidal Ideation" Items 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS at Screening (ie. in the past 1 month) or at any subsequent C-SSRS assessment prior to dosing (ie, since last visit).
- •Subject is at risk of harming him/herself or others according to the Investigator's judgment.
研究组 & 干预措施
SEP-363856
干预措施: SEP-363856 (Drug)
Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole)
干预措施: Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole) (Drug)
结局指标
主要结局
Gastric retention at 4 hr post-radiolabeled meal (gastric emptying scintigraphy (GES) imaging)
时间窗: 4 hours post-radiolabel meal on dosing Day 1 and 2
Gastric retention at 4 hr post-radiolabeled meal is gastric retention 4h post meal, which estimates a percentage of remaining gastric solids in the stomach 4 hours after the meal.
Gastric emptying T 1/2 (gastric emptying scintigraphy (GES) imaging)
时间窗: multiple time-points post-radiolabelled meal on dosing day 1 and 2
Gastric emptying T 1/2 (gastric emptying scintigraphy (GES) imaging) is gastric emptying half life (T1/2), which is a time needed for the half of the ingested gastric solids to leave the stomach.
次要结局
- Gastric retention (proportion retained or % retained) at 1 hr and 2 hr post-radiolabeled meal(1 and 2 hours post-radiolabel meal)