Overview

Pharmacokinetic Interaction Study to Assess the Effect of ASP015K on Tacrolimus in Healthy Volunteers

Status:
Completed
Trial end date:
2009-06-01
Target enrollment:
0
Participant gender:
All
Summary
This study characterizes the pharmacokinetic effects of ASP015K on Tacrolimus in healthy volunteers.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Astellas Pharma Inc
Treatments:
Peficitinib
Tacrolimus
Criteria
Inclusion Criteria:

- 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 observed upon physical examination or 12-lead electrocardiogram (ECG)

- Subjects must weigh at least 45 kg and have a body mass index (BMI) of 18-32 kg/m2

Exclusion Criteria:

- 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, 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