A Study to Assess Drug Interaction of ASP015K and Midazolam

Launched by ASTELLAS PHARMA INC · Aug 11, 2010

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject weighing at least 45kg and 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
• Exclusion Criteria:
• • 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 the 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