A Study to Assess the Relative Bioavailability Between Two ASP015K Tablets and the Food Effect of a New Tablet in Healthy Adult Subjects
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the relative bioavailability of ASP015K under fasting conditions after single-dose administration between a test-tablet formulation and a reference-tablet formulation. This study will also evaluate the food effect on bioavailability of the test formulation, and evaluate the safety and tolerability after single-dose administration of the test- and reference-tablet formulations.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ASP015K Test Tablet - Fasting Conditions ASP015K administered as a single tablet under fasting conditions. |
Drug: ASP015K
oral tablet
|
| Experimental: ASP015K Reference Tablet - Fasting Conditions ASP015K administered via multiple tablets under fasting conditions |
Drug: ASP015K
oral tablet
|
| Experimental: ASP015K Test Tablet -Fed Conditions ASP015K administered as a single tablet under fed conditions |
Drug: ASP015K
oral tablet
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetic parameter of ASP015K: Cmax [Day 1-4 of each treatment period]
Maximum Concentration (Cmax)
- Pharmacokinetic parameter of ASP015K: AUClast [Day 1-4 of each treatment period]
Area Under the Curve from time zero to the last measurable time (AUClast)
- Pharmacokinetic parameter of ASP015K: AUCinf [Day 1-4 of each treatment period]
Area Under the Curve from time zero extrapolated to infinity (AUCinf)
Secondary Outcome Measures
- Composite of pharmacokinetic parameters of ASP015K: tmax, t1/2 [Day 1-4 of each treatment period]
Time to Maximum Concentration (tmax), apparent terminal elimination half-life (t1/2)
- Composite of pharmacokinetic parameters of ASP015K metabolites: Cmax, AUClast, AUCinf, tmax, t1/2 [Day 1-4 of each treatment period]
- Safety assessed by adverse events, clinical laboratory evaluations, 12-lead ECG measurements, physical examinations and vital sign measurements [Up to Day 4 in each treatment period]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Female subject must be of non-childbearing potential (i.e., post-menopausal [defined as at least 1 year without menses prior to screening], or documented surgically sterile or status post hysterectomy [at least 1 month prior to screening]).
-
Female subject must have a negative pregnancy test at screening and day -1 of treatment period 1.
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Female subject must not donate ova starting at screening and throughout the study period, and for 90 days after the final study drug administration.
-
Male subject and his female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at screening and continue throughout the study period and for 90 days after final study drug administration.
-
Male subject must not donate sperm starting at screening and throughout the study period and for 90 days after final study drug administration.
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Subject has a Body Mass Index (BMI) range of 18.5-32.0 kg/m2, inclusive, and must weigh at least 50 kg at screening.
Exclusion Criteria:
-
Female subject who has been pregnant within 6 months before screening assessment or breast feeding within 3 months before screening.
-
Subject has a known or suspected hypersensitivity to ASP015K, or any components of the formulation used.
-
Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
-
Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to first clinic check-in.
-
Subject has used any prescribed or non-prescribed drugs (including vitamins, natural and herbal remedies, e.g., St. John's Wort) in the 2 weeks prior to study drug administration, with the exception of hormone replacement therapy (HRT), intermittent acetaminophen (to a maximum of 2 g/day).
-
Subject has smoked or has used tobacco-containing products and nicotine or nicotine-containing products in the past six months prior to screening.
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Subject has a history of consuming more than 14 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical substance abuse within past 2 years prior to screening (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits) prior to day -1 of treatment period 1.
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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 prior to clinic check-in on day -1 of treatment period 1.
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Subject has a positive test for hepatitis B surface antigen (HBsAg), anti-hepatitis A virus (HAV) (Immunoglobulin [Ig] M), anti-hepatitis C virus (HCV), hepatitis B core antibody, or anti-human immunodeficiency virus (HIV) type 1 or type 2 at screening.
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Subject has a positive tuberculosis (TB) skin test, Quantiferon Gold® test or T-SPOT® test at screening.
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Subject received any vaccine within 60 days prior to study drug administration.
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Subject has an absolute neutrophil count (ANC) < 2000 cells/mm3 or a creatine phosphokinase (CPK) > 1.5 x ULN at screening or day -1 of treatment period 1.
-
Subject has had major gastrointestinal (GI) surgery or has a medical condition, which may inhibit the absorption and/or metabolism of study drug.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Parexel - Early Phase Clinical Unit | Baltimore | Maryland | United States | 21225 |
Sponsors and Collaborators
- Astellas Pharma Global Development, Inc.
- Janssen Biotech, Inc.
Investigators
- Study Director: Medical Director, Astellas Pharma Global Development, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 015K-CL-PK09