Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Astellas Pharma Inc
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.
Age
18–65
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
Subjects must weigh at least 45 kg and have a body mass index (BMI) of 18-32 kg/m2
You may not be if
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, and 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
