A Phase 1, Open-label, Single Dose, Crossover Study to Assess the Relative Bioavailability of Emraclidine Formulations in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
研究概览
简要总结
The objective of this study is to evaluate the pharmacokinetics (PK) and relative bioavailability of emraclidine following single oral administration of different immediate-release (IR) tablet formulations in healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •Body mass index of 18.5 to 32.0 kg/m2, inclusive.
- •Total body weight >= 50 kg.
排除标准
- •History of suicidal ideation within one year prior to study treatment administration and/or history of suicidal behavior or non-suicidal self-injury within two years prior to study treatment administration as evidenced by any "yes" answer to questions on the Columbia-Suicide Severity Rating Scale (C-SSRS) at the screening visit or upon initial confinement.
- •Vital sign measurements, at Screening and Check-in:
- •Systolic blood pressure >= 140 mmHg or < 100 mmHg
- •Diastolic blood pressure >= 90 mmHg or < 60 mmHg
- •Heart rate > 100 bpm or < 50 bpm
- •Orthostatic hypotension, defined as a decrease of >= 20 mmHg in systolic blood pressure upon standing compared with the supine/sitting blood pressure measurement.
- •Female participants of childbearing potential
研究组 & 干预措施
Sequence 4
Participants will receive Emraclidine in 3 different formulations in Sequence 4.
干预措施: Emraclidine (Drug)
Sequence 6
Participants will receive Emraclidine in 3 different formulations in Sequence 6.
干预措施: Emraclidine (Drug)
Sequence 2
Participants will receive Emraclidine in 3 different formulations in Sequence 2.
干预措施: Emraclidine (Drug)
Sequence 5
Participants will receive Emraclidine in 3 different formulations in Sequence 5.
干预措施: Emraclidine (Drug)
Sequence 3
Participants will receive Emraclidine in 3 different formulations in Sequence 3.
干预措施: Emraclidine (Drug)
Sequence 1
Participants will receive Emraclidine in 3 different formulations in Sequence 1.
干预措施: Emraclidine (Drug)