A Study to Evaluate the Pharmacokinetics of Afamelanotide in Patients With Erythropoietic Protoporphyria (EPP)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Cmax (maximum Plasma Concentration)
研究概览
简要总结
The purpose of this study is to evaluate the concentration of afamelanotide in serum after the administration of afamelanotide in adolescent and adult EPP patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •EPP patients aged between 12 and 70 years
- •BMI between 15 and 30 kg/m2
排除标准
- •Any personal or direct family history of melanoma
- •Any significant history of allergy and/or sensitivity to any of the contents of study drug product or lignocaine or other local anaesthetics if used
- •Any significant illness during the four weeks before the study screening period
- •Any evidence of hepatic or renal impairment
研究组 & 干预措施
Afamelanotide 16 mg implant
干预措施: Afamelanotide 16mg implant (Drug)
结局指标
主要结局
Cmax (maximum Plasma Concentration)
时间窗: Baseline to Day 7
Blood samples will be collected for analysis of afamelanotide plasma concentrations and understand what the maximum concentration in plasma is.
AUC(0-t) (area under the curve from administration to last observed concentration at time t)
时间窗: Baseline to Day 7
Blood samples will be collected for analysis of afamelanotide plasma concentrations.
Cmax (Maximum Plasma Concentration)
时间窗: Baseline to Day 7
Blood samples will be collected for analysis of afamelanotide plasma concentrations and understand what the maximum concentration in plasma is.
AUC(0-t) (Area Under the Curve From Administration to Last Observed Concentration at Time t)
时间窗: Baseline to Day 7
Blood samples will be collected for analysis of afamelanotide plasma concentrations.
次要结局
- AUC(0-∞) (area under the curve extrapolated to infinite time)(Baseline to Day 7)
- AUC(0-∞) (Area Under the Curve Extrapolated to Infinite Time)(Baseline to Day 7)