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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01406132
First received: June 30, 2011
Last updated: July 28, 2011
Last verified: July 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Pharmacokinetic assessment through radiographic and high performance liquid chromatography (HPLC) analysis of blood, urine and feces samples [ Time Frame: Up to 10 days ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: December 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP015K Drug: ASP015K
oral

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
  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: 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
  More Information

No publications provided

Responsible Party: Clinical Trials Registry, Astellas Pharma Global Development
ClinicalTrials.gov Identifier: NCT01406132     History of Changes
Other Study ID Numbers: 015K-CL-PK03
Study First Received: June 30, 2011
Last Updated: July 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
ASP015K
Healthy volunteers

ClinicalTrials.gov processed this record on August 28, 2014