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A Study to Assess the Pharmacokinetics of ASP015K in Healthy Male Subjects

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ClinicalTrials.gov Identifier: NCT01406132
Recruitment Status : Completed
First Posted : August 1, 2011
Last Update Posted : August 1, 2011
Sponsor:
Information provided by:
Astellas Pharma Inc

Brief Summary:
The objective of this study is to evaluate pharmacokinetics, in particular the routes of excretion and extent of metabolism of ASP015K after a single oral dose of 14C-labeled ASP015K.

Condition or disease Intervention/treatment Phase
Healthy Subjects Pharmacokinetics of ASP015K Drug: ASP015K Phase 1

Detailed Description:
Eligible subjects will be admitted to the clinical research unit and confined for a minimum of 8 days.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Phase 1, Open-Label, Mass Balance Study to Evaluate the Pharmacokinetics of ASP015K After a Single Oral Dose of 14C-Labeled ASP015K in Healthy Male Subjects
Study Start Date : December 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Arm Intervention/treatment
Experimental: ASP015K Drug: ASP015K
oral



Primary Outcome Measures :
  1. Pharmacokinetic assessment through radiographic and high performance liquid chromatography (HPLC) analysis of blood, urine and feces samples [ Time Frame: Up to 10 days ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The subject has a body weight of at least 45 kg and a body mass index (BMI) between 18 and 32 kg/m2, inclusive
  • The subject has been a non-smoker for at least 3 months prior to check-in
  • The subject agrees to sexual abstinence, is surgically sterile (with documentation provided by a healthcare professional), or is using a medically acceptable method to prevent pregnancy during the study period
  • The subject's clinical laboratory test results are within normal limits
  • The subject is medically healthy, with no clinically significant medical history or abnormalities

Exclusion Criteria:

  • The subject has a history of any clinically significant gastrointestinal, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy excluding non-melanoma skin cancer
  • The subject has a history of malabsorption syndrome or previous gastrointestinal surgery that could affect drug absorption or metabolism
  • The subject has a recent history of irregular defecation, such as constipation or diarrhea
  • The subject has a history of drug or alcohol abuse, or a positive urine screen for alcohol or drugs of abuse/illegal drugs
  • The subject has had treatment with prescription drugs or complementary and alternative medicines (CAM) within 14 days prior to study drug administration, or over the counter (OTC) medication within past week
  • The subject has/had a symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to clinic check in
  • The subject is known positive for human immunodeficiency virus (HIV) antibody
  • The subject has a positive test for hepatitis C antibody, or positive test for hepatitis B antigen (HBsAg)
  • The subject has positive tuberculosis (TB) or Quantiferon Gold test
  • The subject has received an experimental agent within 30 days or five half-lives, whichever is longer, prior to study drug administration
  • The 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 prior to clinic admission
  • The subject has had exposure to significant radiation (eg, serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months prior to check-in
  • The subject has participated in a radio-labeled-study within the last 6 months, participated in more than one other radio-labeled study within the past 12 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01406132


Locations
United States, Wisconsin
Covance Clinical Research Unit (CCRU)
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Medical Director Astellas Pharma Global Development

Responsible Party: Clinical Trials Registry, Astellas Pharma Global Development
ClinicalTrials.gov Identifier: NCT01406132     History of Changes
Other Study ID Numbers: 015K-CL-PK03
First Posted: August 1, 2011    Key Record Dates
Last Update Posted: August 1, 2011
Last Verified: July 2011

Keywords provided by Astellas Pharma Inc:
ASP015K
Healthy volunteers