NCT05933187已完成1 期
A Phase 1, Open-label Trial to Evaluate the Pharmacokinetics and Relative Bioavailability of Emraclidine Following a Single Oral Administration of Immediate-Release Tablets in Healthy Adult Participants
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of Emraclidine
研究概览
简要总结
The purpose of this trial is to evaluate plasma concentrations of emraclidine following single dose oral administration of different emraclidine immediate release (IR) tablets in healthy participants.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sexually active women of childbearing potential must agree to use at least an acceptable birth control method, during the trial and for 7 days after the last dose of investigational medicinal product (IMP)
- •Body mass index of 18.5 to 35.0 kilogram/meter square (kg/m^2), inclusive, and a total body weight ≥50 kg
- •Healthy as determined by medical evaluation, including medical and psychiatric history, physical and neurological examinations, ECG, vital sign measurements, and laboratory test results, as evaluated by the investigator
- •Ability, in the opinion of the investigator, to understand the nature of the trial and comply with protocol requirements, including the prescribed dosage regimens, scheduled visits, laboratory tests, and other trial procedures
排除标准
- •Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus, thyroid disorders), malignancy, hematological, immunological, neurological, or psychiatric disease that, in the opinion of the investigator or medical monitor, could compromise either participant safety or the results of the trial
- •"Yes" responses for any of the following items on the C-SSRS (within the individual's lifetime):
- •Suicidal Ideation Item 3 (Active Suicidal Ideation With Any Methods [Not Plan] Without Intent to Act)
- •Suicidal Ideation Item 4 (Active Suicidal Ideation With Some Intent to Act, Without Specific Plan)
- •Suicidal Ideation Item 5 (Active Suicidal Ideation With Specific Plan and Intent)
- •Any of the Suicidal Behavior items (Actual Attempt, Interrupted Attempt, Aborted Attempt, or Preparatory Acts/Behavior)
- •"Yes" responses for any of the following items on the C-SSRS (within past 12 months):
- •Suicidal Ideation Item 1 (Wish to be Dead)
- •Suicidal Ideation Item 2 (Non-Specific Active Suicidal Thoughts) Serious risk of suicide in the opinion of the investigator is also exclusionary
- •Any condition or surgery that could possibly affect drug absorption, including, but not limited to, bowel resections, bariatric weight loss surgery/procedures, gastrectomy, and cholecystectomy
- •Positive result for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, hepatitis B total core antibody, or hepatitis C antibody with detectable viral ribonucleic acid (RNA) levels at screening
- •Positive drug screen (including cotinine and tetrahydrocannabinol (THC)) or a positive test for alcohol
- •Female participants who are pregnant, breastfeeding, or planning to become pregnant during IMP treatment or within 7 days after the last dose of IMP
- •Known allergy or hypersensitivity to the IMP, closely related compounds, or any of their specified ingredients
- •Received IMP in a clinical trial of emraclidine
- •NOTE: Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of Emraclidine
时间窗: Predose and up to 96 hours post dose in each treatment period
Time to Maximum Plasma Concentration (Tmax) of Emraclidine
时间窗: Predose and up to 96 hours post dose in each treatment period
Area Under the Plasma Concentration-time Curve From Time 0 to the time of Last Quantifiable Concentration (AUC0-t) of Emraclidine
时间窗: Predose and up to 96 hours post dose in each treatment period
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Emraclidine
时间窗: Predose and up to 96 hours post dose in each treatment period
次要结局
- Number of Participants With Clinically Significant Changes in Vital Sign Values(Up to approximately 4 months)
- Changes in Suicidality as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)(Up to approximately 4 months)
- Number of Participants with Treatment Emergent Adverse Events (TEAEs)(Up to approximately 4 months)
- Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results(Screening up to checkout (up to approximately 4 months))
- Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments(Up to approximately 4 months)
- Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Results(Up to approximately 4 months)
研究者
研究点 (2)
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