Clinical trial NCT01486017: A Single Oral Dose Study of ASP015K in Healthy Volunteers Assessing the Relative Bioavailability Across Three Tablet Strengths From a New Formulation of ASP015K
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioavailability of ASP015K
Pharmacokinetics of ASP015K
Healthy Subjects
Keywords: ASP015K
healthy subjects
bioavailability
rheumatoid arthritis
psoriasis
transplantation
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2011-12-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

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
* 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

Primary outcomes:
measure: Composite of pharmacokinetic parameters of ASP015K: Cmax, AUClast, and AUCinf
timeFrame: Up to Day 15
Secondary outcomes:
measure: 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)
timeFrame: Up to Day 15
measure: Composite of pharmacokinetic parameters of ASP015K metabolite H2: Cmax, AUClast, AUCinf, tmax and t1/2
timeFrame: Up to Day 15
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Covance
state: Texas
Study officials:
affiliation: Astellas Pharma Global Development
name: Medical Director
role: STUDY_DIRECTOR
References: