A Phase II, Open-label, Multicentre, Pharmacokinetic, Pharmacodynamic and Safety Study of Anagrelide Hydrochloride in Young (18-50 Years) and Elderly (≥ 65 Years) Patients With Essential Thrombocythaemia.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 24
- 试验地点
- 5
- 主要终点
- AUC of Active Metabolite
研究概览
简要总结
Age related differences in response to a drug could arise from variation in pharmacokinetic (PK) and/or pharmacodynamic (PD) profiles between age groups. Whilst the efficacy and safety profile of anagrelide is well established through a well-documented clinical trial programme in patients of all ages, no formal studies have been carried out to investigate whether the PK profile of anagrelide and its metabolites is altered with age.
This study is designed to allow comparisons to be made in terms of pharmacokinetics of anagrelide and its metabolites between elderly (≥ 65 years) and young (18-50 years) ET patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Young patients aged 18-50 years inclusive or Elderly patients aged 65 years and over
- •Patients must have a confirmed diagnosis of ET.
- •Currently receiving anagrelide hydrochloride at a stable maintenance dose < 5 mg/day for at least 4 weeks.
排除标准
- •Diagnosis of any other myeloproliferative disorder.
- •Current use of tobacco in any form (e.g. smoking or chewing)
- •Treatment with any known enzyme altering agents (barbiturates, phenothiazines, cimetidine etc.) within 30 days prior to or during the study.
- •Patients for whom use of another cytoreductive agent in addition to anagrelide is considered necessary for control of platelet count.
研究组 & 干预措施
Younger Participants (18-50 years)
干预措施: anagrelide hydrochloride (Drug)
Elderly Participants (≥65 years)
干预措施: anagrelide hydrochloride (Drug)
结局指标
主要结局
AUC of Active Metabolite
时间窗: over 1 day
Time of Maximum Plasma Concentration (Tmax) of Agrylin
时间窗: over 1 day
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Agrylin
时间窗: over 1 day
Total Clearance (CL/F) of Agrylin
时间窗: over 1 day
Terminal Half-life (T 1/2) of Agrylin
时间窗: over 1 day
Volume of Distribution (Vz/F) of Agrylin
时间窗: over 1 day
Vz/F of Active Metabolite
时间窗: over 1 day
Maximum Plasma Concentration (Cmax) of Agrylin
时间窗: over 1 day
Cmax of Active Metabolite
时间窗: over 1 day
An active metabolite has therapeutic activity similar to the parent compound and must be considered in therapeutic pharmacokinetics.
Tmax of Active Metabolite
时间窗: over 1 day
T 1/2 of Active Metabolite
时间窗: over 1 day
CL/F of Active Metabolite
时间窗: over 1 day
次要结局
- Systolic Blood Pressure(over 1 day)
- Diastolic Blood Pressure(over 1 day)
- Heart Rate(over 1 day)
- Platelet Count(over 1 day)