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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 25, 2014