ACTRN12614001122640已完成1 期
A single centre, open label, phase I, single ascending dose (SAD) study to investigate the safety, tolerability and pharmacokinetics of oral Capromorelin in spinal cord injury (SCI) and able-bodied volunteers
niversity of Melbourne0 个研究点目标入组 20 人开始时间: 2014年10月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •With/without spinal cord injury between T6 and T12
排除标准
- •Females of child-bearing potential or who were pregnant or breastfeeding.
- •Candidates that were unhealthy (as defined by significant deviation from normal medical history or aberrant results from physical examination/ECG/clinical laboratory determinations), or had a history of toxicities or allergy related to previous treatments.
- •Candidates receiving medications known inhibit /induce CYP3A4.
- •The non-spinal cord injured group comprised able-bodied volunteers.
研究者
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