NCT01486017已完成1 期
A Phase 1, Single-Dose, Open-Label, 3-Period, Randomized Crossover Study to Assess the Relative Bioavailability Across Three Strengths of a New ASP015K Tablet Formulation in Healthy 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
- 30
- 试验地点
- 1
- 主要终点
- Composite of pharmacokinetic parameters of ASP015K: Cmax, AUClast, and AUCinf
研究概览
简要总结
The purpose of this study is to determine the relative bioavailability and pharmacokinetic profiles from three strengths of a new tablet formulation of ASP015K and to evaluate the safety and tolerability after a single dose of three different strengths of a new tablet formulation.
详细描述
Eligible subjects will be admitted on Day-1 and remain confined on the unit for 16 days. Each subject will receive a single dose of study drug per the defined treatment periods on the mornings of Day 1, Day 6 and Day11. There will be a minimum of 5 days between each consecutive dose group. Any subject discontinuing the study prior to completion should have all end of study evaluations completed.
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 weighs at least 45 kg and has a body mass index (BMI) of 18-32 kg/m2
- •Male subject agrees to sexual abstinence, is surgically sterile or is using a medically acceptable method to prevent pregnancy and agrees to continue using this method until 90 days after the last dose of study drug administration
- •Male subject agrees to not donate sperm until 90 days after the dose of study drug administration
- •Female subject is surgically sterile or is post-menopausal and is not pregnant and is not lactating
- •Subject's 12-lead electrocardiogram (ECG) is normal
- •Subject must be capable of swallowing multiple tablets
排除标准
- •Subject has a previous history of any clinically significant gastro-intestinal, neurological, renal, hepatic, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, malignancy excluding non-melanoma skin cancer or any other medical condition
- •Subject has had major GI surgery (such as colectomy, cholecystectomy, etc)
- •Subject has a history of consuming more than 14 units of alcoholic beverages per week or has a history of alcoholism or drug/chemical/ substance abuse within past 2 years
- •Subject has/had a symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week
- •Subject has a positive test for hepatitis C antibody, or positive test for hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody
- •Subject has a history of the human immunodeficiency virus (HIV) antibody
- •Subject has a positive tuberculosis (TB) skin test, Quantiferon Gold test or T-SPOT® test
- •Subject received any vaccine within 60 days
- •Subject received an experimental agent within 30 days
- •Subject has an absolute neutrophil count (ANC) < 2500 cells/mm3
- •Subject has had 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
- •Subject has a history of smoking or has used tobacco-containing products and nicotine or nicotine-containing products in the past six months
研究组 & 干预措施
Treatment B
Experimental
ASP015K oral dose medium strength
干预措施: ASP015K (Drug)
Treatment C
Experimental
ASP015K oral dose high strength
干预措施: ASP015K (Drug)
Treatment A
Experimental
ASP015K oral dose low strength
干预措施: ASP015K (Drug)
结局指标
主要结局
Composite of pharmacokinetic parameters of ASP015K: Cmax, AUClast, and AUCinf
时间窗: Up to Day 15
次要结局
- Composite of pharmacokinetic parameters of ASP015K: tmax, apparent terminal elimination half-life (t1/2), apparent body clearance after oral dosing (CL/F), and apparent volume of distribution (Vz/F)(Up to Day 15)
- Composite of pharmacokinetic parameters of ASP015K metabolite H2: Cmax, AUClast, AUCinf, tmax and t1/2(Up to Day 15)
研究者
研究点 (1)
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