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

Study Overview
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Brief Summary
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This study characterizes the pharmacokinetic effect of ASP015K on mycophenolate mofetil 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 Mycophenolate Mofetil (MMF) After Separate and Concomitant Administration to Healthy Adult Volunteers

Conditions
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Healthy Subjects, Drug Interactions, Pharmacokinetics of ASP015K

Intervention / Treatment
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* Drug: ASP015K
* Drug: Mycophenolate Mofetil


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 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, and 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

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of pharmacokinetic variables through analysis of blood and urine samples |  | Up to 13 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transplant, ASP015K, healthy subjects