NCT07187375进行中（未招募）2 期
A Phase 2, Open-Label Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Pharmacodynamics of Crinecerfont in Pediatric Subjects 0 to <2 Years of Age With Congenital Adrenal Hyperplasia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 7
- 试验地点
- 3
- 主要终点
- Plasma Concentration of Crinecerfont
研究概览
简要总结
The main objective for this study is to evaluate the pharmacokinetics (PK) of crinecerfont in pediatric participants 0 to <2 years of age with congenital adrenal hyperplasia (CAH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be a female or male between 0 to <2 years of age at screening.
- •Have a medically confirmed diagnosis of classic CAH (salt wasting or simple virilizing) due to 21-hydroxylase deficiency (21-OHD).
- •Be on a clinically stable regimen of hydrocortisone (and fludrocortisone, if applicable) treatment.
排除标准
- •Have a known or suspected diagnosis of any of the other forms of classic CAH.
- •Have any condition besides CAH that requires chronic daily therapy with orally administered steroids.
- •Have any other clinically significant medical condition or chronic disease.
- •Note: Other protocol-defined inclusion and exclusion criteria may apply.
研究组 & 干预措施
Crinecerfont
Experimental
Participants with CAH will receive crinecerfont during an initial 14-day treatment period, followed by an optional 36-month open-label extension (OLE).
干预措施: Crinecerfont (Drug)
结局指标
主要结局
Plasma Concentration of Crinecerfont
时间窗: Days 7 and 15
次要结局
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Up to Month 37)
研究者
研究点 (3)
Loading locations...
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