NCT01430065已完成1 期
A Phase 1, Open Label, Single Sequence, Drug Interaction Study of the Pharmacokinetics of ASP015K and Tacrolimus After Separate and Concomitant Administration to Healthy Adult Volunteers
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
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetic assessment of AUC through the analysis of blood and urine samples
研究概览
简要总结
This study characterizes the pharmacokinetic effects of ASP015K on Tacrolimus in healthy volunteers.
详细描述
The subjects will be confined to the unit for 13 days and have a brief follow-up visit to obtain hematology blood samples. Numerous blood and urine samples will be taken to determine the pharmacokinetics of the drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •If female, the subject is at least 2 years post menopausal or is surgically sterile per documentation provided by a third party medical professional and the subject is not pregnant as documented by a negative serum pregnancy test
- •If male, the subject agrees to sexual abstinence and/or to use a highly effective method of birth control during the study period
- •Subject is medically healthy, with no clinically significant medical history or abnormalities observed upon physical examination or 12-lead electrocardiogram (ECG)
- •Subjects must weigh at least 45 kg and have a body mass index (BMI) of 18-32 kg/m2
排除标准
- •Subject has a history of chronic diarrhea
- •Subject has been vaccinated within the last 60 days prior to study drug administration
- •The subject has a previous history of any clinically significant neurological, gastro-intestinal, renal, hepatic, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease
- •Subject has a positive test for hepatitis C antibody, or positive for hepatitis B surface antigen (HBsAg)
- •Subject has a history of the human immunodeficiency virus (HIV) antibody
- •The subject has an absolute neutrophil count (ANC) < 2500 cells/mm3 Subject has had clinically significant illness within 1 month prior to study drug administration
- •Subject has a recent history (within the last 6 months) of drug or alcohol abuse or a positive urine screen for alcohol or drugs of abuse/illegal drugs
研究组 & 干预措施
Tacrolimus and ASP015K
Experimental
干预措施: Tacrolimus (Drug)
Tacrolimus and ASP015K
Experimental
干预措施: ASP015K (Drug)
结局指标
主要结局
Pharmacokinetic assessment of AUC through the analysis of blood and urine samples
时间窗: Up to Day 13
次要结局
- Pharmacokinetic assessment of maximum concentration (Cmax) through the analysis of blood and urine samples(Up to Day 13)
研究者
研究点 (1)
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