A Study to Assess the Relative Bioavailability Between Two ASP015K Tablets and the Food Effect of a New Tablet in Healthy Adult Subjects
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 10/3/2013 |
Start Date: | May 2013 |
End Date: | August 2013 |
Contact: | Astellas Pharma Global Development, Inc. |
Email: | clintrials.info@us.astellas.com |
Phone: | 800-888-7704 |
A Phase 1, Single-Dose, Open-Label, 3-Period, Randomized Crossover Study to Assess the Relative Bioavailability Between Two ASP015K Tablet Formulations and the Food Effect on a New Tablet Formulation in Healthy Adult Subjects
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.
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Subject has a positive tuberculosis (TB) skin test, Quantiferon Gold® test or T-SPOT®
test at screening.
- Subject received any vaccine within 60 days prior to study drug administration.
- 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.
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