NCT01486017
Completed
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- ASP015K
- Conditions
- Bioavailability of ASP015K
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Composite of pharmacokinetic parameters of ASP015K: Cmax, AUClast, and AUCinf
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Treatment B
ASP015K oral dose medium strength
Intervention: ASP015K
Treatment C
ASP015K oral dose high strength
Intervention: ASP015K
Treatment A
ASP015K oral dose low strength
Intervention: ASP015K
Outcomes
Primary Outcomes
Composite of pharmacokinetic parameters of ASP015K: Cmax, AUClast, and AUCinf
Time Frame: Up to Day 15
Secondary Outcomes
- 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)
Study Sites (1)
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