A Phase I, Single-Dose, Open-Label, Three-Period, Randomized, Crossover Study to Compare the Relative Bioavailability Between Two Tablet Formulations of ASP015K and to Assess the Food Effect on a New Formulation in Healthy Volunteers
概览
- 阶段
- 1 期
- 干预措施
- ASP015K
- 疾病 / 适应症
- Pharmacokinetics of ASP015K
- 发起方
- Astellas Pharma Inc
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Composite of pharmacokinetic parameters of ASP015K: C max, AUClast, and AUCinf
- 状态
- 已完成
- 最后更新
- 14年前
概览
简要总结
The purpose of this study is to determine the bioavailability and pharmacokinetics between two different formulations of ASP015K tablets and determine the food effect on the absorption of the new formulation.
详细描述
Eligible subjects will be admitted on Day -2 and remain confined on the unit for 20 days. Each subject will receive a single dose of study drug per the defined treatment periods on the morning of Day 1, Day 8 and Day 15. There will be a minimum of 7 days between each consecutive dose group. For Treatment A, Formulation 1 tablets will be administered within 30 minutes after the start of a standard FDA moderate-fat breakfast. Treatment B, Formulation 2 tablets will be administered in a fasted state. For Treatment C, Formulation 2 tablets will be administered within 30 minutes after the start of a standard FDA moderate-fat breakfast. Any subject discontinuing the study prior to completion should have all end of study evaluations completed
研究者
入排标准
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
- •Subject is willing to take and complete the moderate-fat breakfast within 30 minutes
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
研究组 & 干预措施
Treatment C
ASP015K Formulation 2 with moderate-fat meal
干预措施: ASP015K
Treatment A
ASP015K Formulation 1 with moderate-fat meal
干预措施: ASP015K
Treatment B
ASP015K Formulation 2 under fasting conditions
干预措施: ASP015K
结局指标
主要结局
Composite of pharmacokinetic parameters of ASP015K: C max, AUClast, and AUCinf
时间窗: Up to Day 18
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 18)
- Composite of pharmacokinetic parameters of ASP015K metabolite H2: Cmax, AUClast, AUCinf, tmax and t1/2(Up to Day 18)