A Single Oral Dose Study of ASP015K in Healthy Volunteers Assessing the Relative Bioavailability Across Three Tablet Strengths From a New Formulation of ASP015K
Phase 1
Completed
- Conditions
- Bioavailability of ASP015KPharmacokinetics of ASP015KHealthy Subjects
- Interventions
- Registration Number
- NCT01486017
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment A ASP015K ASP015K oral dose low strength Treatment C ASP015K ASP015K oral dose high strength Treatment B ASP015K ASP015K oral dose medium strength
- Primary Outcome Measures
Name Time Method Composite of pharmacokinetic parameters of ASP015K: Cmax, AUClast, and AUCinf Up to Day 15
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Covance
🇺🇸Dallas, Texas, United States