A Study to Assess the Systemic Disposition of ASP1585 After Administration of 14C-labeled Drug

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01124747
First received: May 14, 2010
Last updated: May 25, 2010
Last verified: May 2010
  Purpose

The objective of this study is to assess the systemic disposition of ASP1585 after oral administration of 14C-labeled drug in healthy male subjects.


Condition Intervention Phase
Healthy
Pharmacokinetics of ASP1585
Drug: ASP1585
Drug: 14C-Labeled ASP1585
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: An Open-Label Study to Evaluate the Disposition of 14C-Labeled ASP1585 in Healthy Male Volunteers

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Excretion of radioactivity in urine [ Time Frame: Day 15 and up to Day 24 ] [ Designated as safety issue: No ]
  • Excretion of radioactivity in feces [ Time Frame: Day 15 and up to Day 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Radioactivity assessment through analysis of blood samples [ Time Frame: Day 15 and up to Day 24 ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: April 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP1585 and 14C-Labeled ASP1585 Drug: ASP1585
Oral
Drug: 14C-Labeled ASP1585
Oral

Detailed Description:

Subjects will receive study drug for 18 days with a radioactive dose of study drug given on Day 15. Blood, urine and feces will be collected to confirm recovery of radioactivity.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body Mass Index (BMI) between 18 and 32 kg/m2, inclusive and minimum body weight 45 kg
  • Agrees to sexual abstinence or to use a highly effective form of birth control which includes a barrier method throughout the study
  • In good health

Exclusion Criteria:

  • History of any clinically significant disease
  • History of bowel obstruction, swallowing disorders, gastrointestinal disorders, gastrointestinal surgery, actively bleeding hemorrhoids, or gastric/duodenal ulcers
  • Irregular bowel habits (<1 bowel movement per day)
  • Clinically significant illness within 30 days
  • Received any drug or medicine (prescription or over-the-counter), including topical medications, complementary and alternative medicines and vitamin and mineral supplements within 14 days prior to the first dose of study drug
  • Received any investigational medication during the last 30 days or 5 half-lives, whichever is longer, prior to screening
  • Consumes >10 units of alcohol per week or history of alcoholism or drug/chemical abuse within past 2 years
  • Smokes cigarettes or other nicotine-containing products
  • Anticipates an inability to abstain from alcohol use for 48 hours prior to first dose of study drug or from grapefruit, Seville oranges, star fruit or products containing these items from 72 hours prior to first dose of study drug until end of study
  • Positive drug or alcohol screen at Screening or Day -1
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or gamma-glutamyl transferase (GGT) value of >2x upper limit of normal at Screening or Day -1
  • Known positive for human immunodeficiency virus (HIV), Hepatitis A, Hepatitis B or Hepatitis C
  • Unwilling or unable to swallow large numbers of capsules
  • Significant blood loss, donated one unit of blood or more, or received a transfusion of any blood or blood product within 60 days or donated plasma within 7 days prior to Day -1
  • Known cumulative radiation exposure >5 rems for the whole body, active blood forming organs, ocular lens, and gonads, and >15 rems for other organs
  • Has had nuclear medicine procedures, computed tomography scans, or significant x-rays (other than dental) within the past 12 months, has received radiolabeled material within the last 6 months, or has had significant occupational radiation exposure
  • Has participated in a radiolabled study within the last 6 months or participated in more than one radiolabeled study within the last 12 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01124747

Locations
United States, Wisconsin
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma Global Development
  More Information

No publications provided

Responsible Party: Sr Manager Clinical Trials Registry, Astellas Pharma Global Development
ClinicalTrials.gov Identifier: NCT01124747     History of Changes
Other Study ID Numbers: 1585-CL-0011
Study First Received: May 14, 2010
Last Updated: May 25, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
ASP1585
Healthy Volunteers

ClinicalTrials.gov processed this record on April 17, 2014