Overview

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