A Study to Evaluate the Drug Interaction of ASP015K and Tacrolimus

A Phase 1, Open Label, Drug Interaction Study of the Pharmacokinetics of ASP015K and Tacrolimus After Separate and Concomitant Administration to Healthy Adult Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Pharmacokinetics of ASP015K and Tacrolimus
• Intervention / Treatment: Drug: Tacrolimus; Drug: ASP015K

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Hawaii
    • Honolulu, Hawaii, United States, 96813

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1, Group 1; ASP015K, low dose followed by high dose, with oral tacrolimus	Drug: Tacrolimus; Oral and Intravenous; Other Names: Prograf; FK506; Drug: ASP015K; Oral
Experimental: Part 1, Group 2; ASP015K, high dose followed by low dose, with oral tacrolimus	Drug: Tacrolimus; Oral and Intravenous; Other Names: Prograf; FK506; Drug: ASP015K; Oral
Experimental: Part 2; ASP015K high dose with intravenous tacrolimus	Drug: Tacrolimus; Oral and Intravenous; Other Names: Prograf; FK506; Drug: ASP015K; Oral

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: August 11, 2010
• First Submitted That Met QC Criteria: August 27, 2010
• First Posted (Estimate): August 30, 2010

Study Record Updates

• Last Update Posted (Estimate): October 14, 2010
• Last Update Submitted That Met QC Criteria: October 12, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: healthy volunteers; tacrolimus; ASP015K
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus; Peficitinib
• Other Study ID Numbers: 015K-CL-PK16