A Single Oral Dose Study of ASP015K in Healthy Volunteers Assessing the Relative Bioavailability Across Three Tablet Strengths From a New Formulation of ASP015K

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01486017
First received: December 1, 2011
Last updated: December 2, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Bioavailability of ASP015K
Pharmacokinetics of ASP015K
Healthy Subjects
Drug: ASP015K
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Composite of pharmacokinetic parameters of ASP015K: Cmax, AUClast, and AUCinf [ Time Frame: Up to Day 15 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) [ Time Frame: Up to Day 15 ] [ Designated as safety issue: No ]
  • Composite of pharmacokinetic parameters of ASP015K metabolite H2: Cmax, AUClast, AUCinf, tmax and t1/2 [ Time Frame: Up to Day 15 ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: September 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A
ASP015K oral dose low strength
Drug: ASP015K
oral
Experimental: Treatment B
ASP015K oral dose medium strength
Drug: ASP015K
oral
Experimental: Treatment C
ASP015K oral dose high strength
Drug: ASP015K
oral

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486017

Locations
United States, Texas
Covance
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Medical Director Astellas Pharma Global Development
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01486017     History of Changes
Other Study ID Numbers: 015K-CL-PK18
Study First Received: December 1, 2011
Last Updated: December 2, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
ASP015K
healthy subjects
bioavailability
rheumatoid arthritis
psoriasis
transplantation

ClinicalTrials.gov processed this record on April 16, 2014