NCT00920608撤回1 期
A Phase I, Multi-centre, Open-label, Fixed-sequence Study to Assess the Pharmacokinetics of Methotrexate Alone and When Co-administered With AZD9056 in Subjects With Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- AstraZeneca
- 入组人数
- 12
- 主要终点
- Pharmacokinetics of AZD9056 and Methotrexate
研究概览
简要总结
The main aim of this clinical study is to investigate whether the blood concentration of methotrexate changes when AZD9056 is co- administered together with methotrexate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with rheumatoid arthritis
- •Currently on Methotrexate treatment
- •Provision of informed consent
排除标准
- •History of malignancy (except for treated squamous and basal cell carcinoma of the skin more than 5 years prior to entry)
- •Patients who were taking prescription of medications listed below:
- •Medications that are hepatic enzyme inducers and that were inhibitors of cytochrome P450, Lovastatin
- •Leflunomide, hydroxychloroquine, cyclosporin or anti-tumour necrosis factor therapies within 90 days of Visit 1, or treatment with rituximab within 1 year before Visit 1
研究组 & 干预措施
A
Experimental
AZD9056 400 mg and Methotrexate
干预措施: AZD9056 (Drug)
A
Experimental
AZD9056 400 mg and Methotrexate
干预措施: Methotrexate (Drug)
结局指标
主要结局
Pharmacokinetics of AZD9056 and Methotrexate
时间窗: Pharmacokinetic samples for Methotrexate taken at baseline and and at steady state.Pharmacokinetc samples for AZD9056 taken at steady state
次要结局
- Pharmacokinetics of AZD9056 and 7-OH Methotrexate(Pharmacokinetics samples for 7-OH Methotrexate taken at baseline and and at steady state.Pharmacokinetc samples for AZD9056 taken at steady state)
- Safety and tolerability (Physical examination, vital signs, electrocardiogram (ECG), safety laboratory,adverse events.)(During the whole study)
研究者
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