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CompletedNCT01406132Updated Aug 1, 2011

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

A Phase 1 interventional study of ASP015K in Healthy Subjects and Pharmacokinetics of ASP015K, sponsored by Astellas Pharma Inc. Completed at 1 site in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-08-01.

Sponsored by Astellas Pharma Inc · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Healthy Subjects
  • Pharmacokinetics of ASP015K

Keywords

  • ASP015K
  • Healthy volunteers
03

In context

Lead sponsor

Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    ASP015K

    Drug: ASP015K

Interventions

  • DrugASP015K

    oral

06

What researchers measure

Primary outcomes

  1. Pharmacokinetic assessment through radiographic and high performance liquid chromatography (HPLC) analysis of blood, urine and feces samples

    Time frame: Up to 10 days

07

Study locations

1 site
  • Covance Clinical Research Unit (CCRU)
    Madison, Wisconsin 53704, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01406132
Lead sponsor
Astellas Pharma Inc
First posted
Aug 1, 2011
Start date
Dec 2009
Primary completion
Jan 2010
Completion
Jan 2010
Last update
Aug 1, 2011

Study contacts

Medical Director
study director · Astellas Pharma Global Development

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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