NCT01309854已完成1 期
An Open-Label, Single Center Study to Assess the Pharmacokinetics of Pioglitazone in Healthy Subjects When Administered Alone and in Combination With Fostamatinib 100 mg Twice Daily
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 assess pharmacokinetics (PK) of pioglitazone including but not limited to AUC and Cmax
研究概览
简要总结
The purpose of this study is to investigate the drug interaction between fostamatinib and pioglitazone by comparing the safety, tolerability and plasma concentration of pioglitazone when administered alone and with fostamatinib in healthy subjects.
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
- •Males or females (of non-child bearing potential) aged 18 to 55 years (inclusive)
- •Minimum weight of 50 kg and a body mass index (BMI) of 18 to 35 kg/m2 (inclusive)
- •Males must be willing to use barrier contraception ie, condoms, from the first administration until 2 weeks after the last administration of the investigational product
排除标准
- •History or presence of gastrointestinal, hepatic or renal disease (except for cholecystectomy)
- •Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the investigational product
- •Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day
- •Absolute neutrophil count of less than 2500/mm3 or 2.5 x 109/L
- •Any previous treatment with fostamatinib or pioglitazone
研究组 & 干预措施
pioglitazone
Experimental
干预措施: fostamatinib (Drug)
pioglitazone
Experimental
干预措施: pioglitazone (Drug)
pioglitazone and fostamatinib
Experimental
干预措施: pioglitazone (Drug)
结局指标
主要结局
To assess pharmacokinetics (PK) of pioglitazone including but not limited to AUC and Cmax
时间窗: Period 2: Pre-dose to 48h post dose
次要结局
- To assess pharmacokinetics (PK) of hydroxypioglitazone (active metabolite) including but not limited to AUC and Cmax(Period 2: Pre-dose to 48h post dose)
- To examine the safety and tolerability(From screening, Day -1 to Day 9 and follow up visit (Day 16))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Effects of Administration of Fostamatinib on Blood Concentrations of Warfarin in Healthy SubjectsHealthy SubjectsRheumatoid ArthritisNCT01311622AstraZeneca15
已完成
1 期
Effects of Administration of Fostamatinib on Blood Concentrations of Rifampicin in Healthy Subjects.Healthy VolunteersRheumatoid ArthritisNCT01336218AstraZeneca15
已完成
1 期
Clinical Trial of Combined Fostamatinib and Paclitaxel in Ovarian CancerOvarian CancerNCT03246074Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins27
已完成
1 期
Evaluation of the Drug-drug Interaction Between FosD and Verapamil When Taken Together in Healthy VolunteersDrug Drug InteractionsHealthy VolunteersNCT01197781AstraZeneca15
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