NCT00446082已完成1 期
A Phase I, Multicenter, Open-label, Randomized Study Assessing the Pharmacokinetics, Safety, and Tolerability of Monthly Doses of Pasireotide i.m. LAR Injection in Patients With Acromegaly and Patients With Carcinoid Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 5
- 主要终点
- Determination of the pharmacokinetic profile of single and monthly doses of pasireotide LAR i.m. injection
研究概览
简要总结
This study will assess the pharmacokinetic profile and the safety/tolerability profile of single and monthly doses of pasireotide LAR intramuscular (i.m.) injection in patients with acromegaly and patients with carcinoid disease
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SOM230 LAR
Experimental
干预措施: Pasireotide (Drug)
结局指标
主要结局
Determination of the pharmacokinetic profile of single and monthly doses of pasireotide LAR i.m. injection
时间窗: Baseline, D7, D35, D63
in patients with acromegaly and in patients with carcinoid disease
次要结局
- To explore the pharmacodynamic profile of single and monthly doses of pasireotide LAR i.m. injection(Baseline, D7, D35, D63)
研究者
研究点 (5)
Loading locations...
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