NCT07253272已完成1 期
An Open-label Positron Emission Tomography (PET) Study to Demonstrate Safety, Tolerability, Receptor Occupancy, and Pharmacokinetics After a Single Oral Dose Administration of ENX-104 in Healthy Volunteers
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Participants with Treatment Emergent Adverse Events (TEAE)
研究概览
简要总结
The study is designed to evaluate the D2/D3 receptor occupancy (RO), safety, tolerability, and pharmacokinetics (PK) of ENX-104 in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 23 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Biologically female participants (defined as assigned female at birth)
- •Of non-childbearing potential, defined as either permanently sterilized or postmenopausal and with a negative pregnancy test
- •Not currently breastfeeding or lactating, and not intending to initiate breastfeeding during the course of study conduct
- •Biologically male participants (defined as assigned male at birth), if fertile must be willing to use a condom or remain abstinent. Participants assigned male at birth should use a highly effective method of birth control and refrain from sexual activity with partners of childbearing potential who do not use a highly effective method of birth control during the study. Participants assigned male at birth who are not surgically sterilized for at least 90 days prior to Screening and are sexually active with partner(s) of childbearing potential, must agree to refrain from sperm donation.
排除标准
- •Unable or unwilling to comply with the requirements of the study or, in the opinion of the Investigator or Sponsor, should not participate in the study.
研究组 & 干预措施
ENX-104
Experimental
干预措施: ENX-104 (Drug)
结局指标
主要结局
Number of Participants with Treatment Emergent Adverse Events (TEAE)
时间窗: From Day 1 up to Day 9
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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