Healthy Subjects Clinical Trial
Official title:
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
Verified date | December 2011 |
Source | Astellas Pharma Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | September 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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-SPOTĀ® 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 |
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | Covance | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
Astellas Pharma Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite of pharmacokinetic parameters of ASP015K: Cmax, AUClast, and AUCinf | Up to Day 15 | No | |
Secondary | 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 | No | |
Secondary | Composite of pharmacokinetic parameters of ASP015K metabolite H2: Cmax, AUClast, AUCinf, tmax and t1/2 | Up to Day 15 | No |
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