A Single Oral Dose Study of ASP015K in Healthy Volunteers Assessing the Relative Bioavailability Across Three Tablet Strengths From a New Formulation of ASP015K

Age

18–55

Sex

ALL

Healthy volunteers

Accepted

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 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