A Study to Evaluate the Drug Interaction of ASP015K and Tacrolimus

Phase 1

Completed

• Conditions: Healthy; Pharmacokinetics of ASP015K and Tacrolimus
• Interventions: Drug: Tacrolimus; Drug: ASP015K

• Registration Number: NCT01190670
• Lead Sponsor: Astellas Pharma Inc

Brief 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.

Detailed Description

This is a 2-part study. Part 1 is a 2-sequence, drug interaction study to determine the effect of two different ASP015K doses on the pharmacokinetics of oral tacrolimus. Part 2 is a 1-sequence drug interaction study to determine the effect of the higher dose ASP015K on the pharmacokinetics of IV tacrolimus.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-08-11
• Study First Submitted QC: 2010-08-27
• Study First Posted: 2010-08-30
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-12
• Last Update Posted: 2010-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part 1, Group 1	Tacrolimus	ASP015K, low dose followed by high dose, with oral tacrolimus
Part 1, Group 1	ASP015K	ASP015K, low dose followed by high dose, with oral tacrolimus
Part 1, Group 2	Tacrolimus	ASP015K, high dose followed by low dose, with oral tacrolimus
Part 1, Group 2	ASP015K	ASP015K, high dose followed by low dose, with oral tacrolimus
Part 2	Tacrolimus	ASP015K high dose with intravenous tacrolimus
Part 2	ASP015K	ASP015K high dose with intravenous tacrolimus

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic variables assessment through analysis of blood and urine samples	Days 1-13 and Days 26-33 (Part 1 only) sampled daily