A Phase 1, Open Label, Drug Interaction Study of the Pharmacokinetics of ASP015K and Tacrolimus After Separate and Concomitant Administration to Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Pharmacokinetic variables assessment through analysis of blood and urine samples
研究概览
简要总结
The objective of the study is to characterize the effect of multiple doses of ASP015K on the pharmacokinetics of a single oral dose or a single intravenous (IV) dose of tacrolimus.
详细描述
This is a 2-part study. Part 1 is a 2-sequence, drug interaction study to determine the effect of two different ASP015K doses on the pharmacokinetics of oral tacrolimus. Part 2 is a 1-sequence drug interaction study to determine the effect of the higher dose ASP015K on the pharmacokinetics of IV tacrolimus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Subject weighing at least 45kg and body mass index (BMI) of 18-32 kg/m2, inclusive
- •If female, 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, subject agrees to sexual abstinence, is surgically sterile, or is using a medically acceptable method to prevent pregnancy during the study period
- •12-lead ECG is normal or if abnormal, the abnormality is not clinically significant
- •Clinical laboratory test results are within normal limits or not clinically significant
- •Medically healthy, with no clinically significant medical history or abnormalities
排除标准
- •History of any clinically significant disorder, disease or malignancy excluding non-melanoma skin cancer
- •Recent history (within 6 months) of drug or alcohol abuse or positive urine screen for drugs of abuse/illegal drugs
- •Treatment with prescription drugs or complementary and alternative medicines (CAM) within 14 days prior to study drug administration, or over the counter medication within 1 week prior to study drug administration
- •A symptomatic, viral, bacterial or fungal infection within 1 week prior to clinic check-in
- •Positive test for hepatitis C antibody, or positive test for hepatitis B surface antigen (HBsAg)
- •History of human immunodeficiency virus (HIV) antibody
- •Positive tuberculosis (TB) skin test or Quantiferon Gold test
- •Vaccinated within the last 30 days prior to study drug administration
- •Received an experimental agent within 30 days or five half-lives, whichever is longer, prior to study drug administration
- •Any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission
- •Absolute neutrophil count (ANC) <2500 cells/mm3
研究组 & 干预措施
Part 1, Group 1
ASP015K, low dose followed by high dose, with oral tacrolimus
干预措施: Tacrolimus (Drug)
Part 1, Group 1
ASP015K, low dose followed by high dose, with oral tacrolimus
干预措施: ASP015K (Drug)
Part 1, Group 2
ASP015K, high dose followed by low dose, with oral tacrolimus
干预措施: Tacrolimus (Drug)
Part 1, Group 2
ASP015K, high dose followed by low dose, with oral tacrolimus
干预措施: ASP015K (Drug)
Part 2
ASP015K high dose with intravenous tacrolimus
干预措施: Tacrolimus (Drug)
Part 2
ASP015K high dose with intravenous tacrolimus
干预措施: ASP015K (Drug)
结局指标
主要结局
Pharmacokinetic variables assessment through analysis of blood and urine samples
时间窗: Days 1-13 and Days 26-33 (Part 1 only) sampled daily
次要结局
未报告次要终点