A Study to Evaluate the Drug Interaction of ASP015K and Tacrolimus

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the study is to characterize the effect of multiple doses of ASP015K on the pharmacokinetics of a single oral dose or a single intravenous (IV) dose of tacrolimus.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Peficitinib; Tacrolimus

Criteria

Inclusion Criteria:

• Subject weighing at least 45kg and body mass index (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

• 12-lead ECG is normal or if abnormal, the abnormality is not clinically significant

• Clinical laboratory test results are within normal limits or not clinically significant

• Medically healthy, with no clinically significant medical history or abnormalities

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 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