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

Study Overview
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Brief Summary
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This study characterizes the pharmacokinetic effects of ASP015K on Tacrolimus in healthy volunteers.

Detailed Description
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The subjects will be confined to the unit for 13 days and have a brief follow-up visit to obtain hematology blood samples. Numerous blood and urine samples will be taken to determine the pharmacokinetics of the drugs.

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

Conditions
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Pharmacokinetics of ASP015K, Drug Interactions, Healthy Subjects

Intervention / Treatment
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* Drug: ASP015K
* Drug: Tacrolimus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tacrolimus and ASP015K<br> | Drug: ASP015K<br>* oral<br>Drug: Tacrolimus<br>* oral<br>* Other names: FK506;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic assessment of AUC through the analysis of blood and urine samples |  | Up to Day 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic assessment of maximum concentration (Cmax) through the analysis of blood and urine samples |  | Up to Day 13 | 

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