A Double-Blind, Escalating Dose Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Evaluation of Repeat Doses of EVP-6308 or Placebo in Subjects With Schizophrenia on a Stable Antipsychotic Regimen
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Safety and tolerability of EVP-6308 in subjects with schizophrenia currently receiving stable treatment with up to 2 atypical antipsychotics
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, sequential cohort, ascending oral dose study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of EVP-6308 administered for 14 days in subjects with schizophrenia who are on a stable anti-psychotic regimen.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with schizophrenia, male or female subjects, 18 to 60 years of age
排除标准
- •Clinically significant abnormalities on physical examination, medical history, ECG, vital signs, laboratory values, or unstable medical or psychiatric illness
- •Any disorder that may interfere with drug absorption
- •Clinically significant allergy or sensitivity to medications Positive test for human immunodeficiency virus (HIV) antibodies, Hepatitis B surface antigen, or Hepatitis C antibody
- •Pregnant or breast feeding
研究组 & 干预措施
Placebo Comparator; Arm 4
Placebo, Capsule, Once Daily, Day 1 through Day 14
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability of EVP-6308 in subjects with schizophrenia currently receiving stable treatment with up to 2 atypical antipsychotics
时间窗: Baseline to Day 21 or Early Termination
Vital signs measurements, Clinical laboratory tests, Physical examination, ECG findings, Columbia-Suicide Severity Rating Scale. Adverse events and concomitant medications will be collected from the time of signing the informed consent.
次要结局
- Pharmacokinetics of EVP-6308 in subjects with schizophrenia and the potential for EVP-6308 to affect the pharmacokinetic properties of the antipsychotic regimen(Day -1 through Day 16)
- Potential pharmacodynamics effects of EVP-6308(Baseline to Day 21 or Early Termination)