NCT04972227已完成1 期
A Double-blinded, Randomized, Placebo-controlled, Multiple-ascending-dose Study to Assess the Safety and Pharmacokinetics of CY6463 in Participants With Stable Schizophrenia
Tisento Therapeutics2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2021年9月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to study drug discontinuation
研究概览
简要总结
The primary objective of this study is to evaluate the safety and tolerability of CY6463 when administered to participants with stable schizophrenia who are on a stable antipsychotic medication regimen
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
CY6463
Experimental
CY6463 once-daily (QD) for 14 days
干预措施: CY6463 (Drug)
Placebo
Placebo Comparator
placebo QD for 14 days
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to study drug discontinuation
时间窗: 28 (±4) days
次要结局
- Plasma concentrations of CY6463(up to Day 15)
- PK parameter: maximum observed concentration (Cmax)(up to Day 15)
- PK parameter: time to maximum observed concentration (Tmax)(up to Day 15)
- PK parameter: minimum observed concentration (Cmin)(up to Day 15)
- PK parameter: apparent systemic clearance (CL/F)(up to Day 15)
- PK parameter: accumulation ratio based on a comparison of AUC values after single and multiple dosing (RAUC)(up to Day 15)
- PK parameter: accumulation ratio based on a comparison of Cmax values after single and multiple dosing (RCmax)(up to Day 15)
- Pharmacokinetic (PK) parameter: area under the concentration-time curve from time zero (predose) to 24 hours postdose (AUC0-24)(up to Day 15)
- PK parameter: area under the concentration-time curve during a dosing interval (AUCtau)(up to Day 15)
- PK parameter: average concentration during a dosing interval (Cavg)(up to Day 15)
研究者
研究点 (2)
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