A Study to Evaluate the Drug Interaction of ASP015K and Tacrolimus

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy, Pharmacokinetics of ASP015K and Tacrolimus

Intervention / Treatment
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* Drug: Tacrolimus
* Drug: ASP015K


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1, Group 1<br>ASP015K, low dose followed by high dose, with oral tacrolimus | Drug: Tacrolimus<br>* Oral and Intravenous<br>* Other names: Prograf;Drug: ASP015K<br>* Oral<br>|
| Experimental: Part 1, Group 2<br>ASP015K, high dose followed by low dose, with oral tacrolimus | Drug: Tacrolimus<br>* Oral and Intravenous<br>* Other names: Prograf;Drug: ASP015K<br>* Oral<br>|
| Experimental: Part 2<br>ASP015K high dose with intravenous tacrolimus | Drug: Tacrolimus<br>* Oral and Intravenous<br>* Other names: Prograf;Drug: ASP015K<br>* Oral<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASP015K, tacrolimus, healthy volunteers