A Single Oral Dose Study of ASP015K in Healthy Volunteers Assessing the Relative Bioavailability Across Three Tablet Strengths From a New Formulation of ASP015K

Study Overview
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Brief Summary
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The purpose of this study is to determine the relative bioavailability and pharmacokinetic profiles from three strengths of a new tablet formulation of ASP015K and to evaluate the safety and tolerability after a single dose of three different strengths of a new tablet formulation.

Detailed Description
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Eligible subjects will be admitted on Day-1 and remain confined on the unit for 16 days. Each subject will receive a single dose of study drug per the defined treatment periods on the mornings of Day 1, Day 6 and Day11. There will be a minimum of 5 days between each consecutive dose group. Any subject discontinuing the study prior to completion should have all end of study evaluations completed.

Official Title
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A Phase 1, Single-Dose, Open-Label, 3-Period, Randomized Crossover Study to Assess the Relative Bioavailability Across Three Strengths of a New ASP015K Tablet Formulation in Healthy Volunteers

Conditions
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Bioavailability of ASP015K, Pharmacokinetics of ASP015K, Healthy Subjects

Intervention / Treatment
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* Drug: ASP015K


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject weighs at least 45 kg and has a body mass index (BMI) of 18-32 kg/m2 Male subject agrees to sexual abstinence, is surgically sterile or is using a medically acceptable method to prevent pregnancy and agrees to continue using this method until 90 days after the last dose of study drug administration Male subject agrees to not donate sperm until 90 days after the dose of study drug administration Female subject is surgically sterile or is post-menopausal and is not pregnant and is not lactating Subject's 12-lead electrocardiogram (ECG) is normal Subject must be capable of swallowing multiple tablets Exclusion Criteria: Subject has a previous history of any clinically significant gastro-intestinal, neurological, renal, hepatic, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, malignancy excluding non-melanoma skin cancer or any other medical condition Subject has had major GI surgery (such as colectomy, cholecystectomy, etc) Subject has a history of consuming more than 14 units of alcoholic beverages per week or has a history of alcoholism or drug/chemical/ substance abuse within past 2 years Subject has/had a symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week Subject has a positive test for hepatitis C antibody, or positive test for hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody Subject has a history of the human immunodeficiency virus (HIV) antibody Subject has a positive tuberculosis (TB) skin test, Quantiferon Gold test or T-SPOT® test Subject received any vaccine within 60 days Subject received an experimental agent within 30 days Subject has an absolute neutrophil count (ANC) < 2500 cells/mm3 Subject has had 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 Subject has a history of smoking or has used tobacco-containing products and nicotine or nicotine-containing products in the past six months

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: Treatment A<br>ASP015K oral dose low strength | Drug: ASP015K<br>* oral<br>|
| Experimental: Treatment B<br>ASP015K oral dose medium strength | Drug: ASP015K<br>* oral<br>|
| Experimental: Treatment C<br>ASP015K oral dose high strength | Drug: ASP015K<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of pharmacokinetic parameters of ASP015K: Cmax, AUClast, and AUCinf |  | Up to Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of pharmacokinetic parameters of ASP015K: tmax, apparent terminal elimination half-life (t1/2), apparent body clearance after oral dosing (CL/F), and apparent volume of distribution (Vz/F) |  | Up to Day 15 | 
| Composite of pharmacokinetic parameters of ASP015K metabolite H2: Cmax, AUClast, AUCinf, tmax and t1/2 |  | Up to Day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASP015K, healthy subjects, bioavailability, rheumatoid arthritis, psoriasis, transplantation