NCT01311622已完成1 期
An Open-Label, Single Centre Study to Assess the Pharmacokinetics and Pharmacodynamics of Warfarin When Co-Administered With Fostamatinib in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- To determine PK parameters of R- and S-warfarin including but not limited to AUC and Cmax
研究概览
简要总结
The purpose of this study is to determine whether fostamatinib influences the plasma concentration of warfarin and changes its blood thinning effect, and to investigate how safe and tolerable it is when administered with warfarin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of informed consent prior to any study specific procedures (including genotyping screening sample for CYP2C9 and VKORC1).
- •Males or females (of non-childbearing potential) aged 18 to 55 years (inclusive)
- •Subjects must be negative for occult blood (stool card) prior to administration.
- •Body weight of at least 50 kg and body mass index (BMI) between 18 and 35 kg/m2 inclusive
排除标准
- •History of any clinically significant disease or disorder which, in the opinion of the Investigator, may put the subject at risk because of participation in the study, or influence the results of the study.
- •Healthy subject predicted to be most sensitive to warfarin based on CYP2C9 and VKORC1 genotypes.
- •A protein C and/or protein S deficiency.
- •Absolute neutrophil count of less than 2500/mm3 or 2.5 x 109/L
- •Previous treatment with warfarin for a clinical indication (ie, participation in a previous warfarin interaction study is acceptable).
研究组 & 干预措施
warfarin
Experimental
干预措施: warfarin (Drug)
warfarin and fostamatinib
Experimental
干预措施: warfarin (Drug)
warfarin and fostamatinib
Experimental
干预措施: fostamatinib (Drug)
结局指标
主要结局
To determine PK parameters of R- and S-warfarin including but not limited to AUC and Cmax
时间窗: From pre-dose to 168 h post dose relative to each single warfarin dose
* Pharmacokinetics of warfarin measured by AUC * Pharmacokinetics of warfarin measured Cmax
次要结局
- To measure International Normalised Ratio (INR) following administration of warfarin(From pre-dose to 168 h post dose relative to each single warfarin dose)
- To assess the steady-state pharmacokinetics of R406 (active metabolite of fostamatinib) by measuring AUCss, Cmax,ss, tmax,ss and CL/F(From predose on Day 11 until 12 h post dose on Day 14 relative to fostamatinib dosing)
- Safety and tolerability will be measured with regard to adverse events, laboratory assessments, vital signs, physical examination, and 12-lead ECG will be recorded.(From screening, Day -1 to Day 21 and follow up visit (Day 28))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA)Warm Antibody Autoimmune Hemolytic AnemiaNCT02612558Rigel Pharmaceuticals26
已完成
1 期
Effects of Administration of Fostamatinib on Blood Concentrations of Pioglitazone in Healthy SubjectsHealthy VolunteersPharmacokineticsPioglitazoneDrug-drug InteractionAmount of Pioglitazone in BloodRheumatoid ArthritisNCT01309854AstraZeneca15
已完成
1 期
A Study of Fostamatinib in Subjects With Impaired Hepatic (Liver) FunctionHealthy VolunteersPharmacokineticsHepatic ImpairmentAmount of R406 in BloodNCT01222455AstraZeneca32
已完成
2 期
Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) NephropathyIGA NephropathyNCT02112838Rigel Pharmaceuticals76
已完成
3 期
A Efficacy and Safety Study of Fostamatinib in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)Immune Thrombocytopenic PurpuraNCT02076412Rigel Pharmaceuticals74