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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01124747
Recruitment Status : Completed
First Posted : May 17, 2010
Last Update Posted : May 5, 2014
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Pharmacokinetics of ASP1585 Drug: ASP1585 Drug: 14C-Labeled ASP1585 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: An Open-Label Study to Evaluate the Disposition of 14C-Labeled ASP1585 in Healthy Male Volunteers
Study Start Date : April 2010
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Arm Intervention/treatment
Experimental: ASP1585 and 14C-Labeled ASP1585 Drug: ASP1585

Drug: 14C-Labeled ASP1585

Primary Outcome Measures :
  1. Excretion of radioactivity in urine [ Time Frame: Day 15 and up to Day 24 ]
  2. Excretion of radioactivity in feces [ Time Frame: Day 15 and up to Day 24 ]

Secondary Outcome Measures :
  1. Radioactivity assessment through analysis of blood samples [ Time Frame: Day 15 and up to Day 24 ]

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT01124747

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

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT01124747     History of Changes
Other Study ID Numbers: 1585-CL-0011
First Posted: May 17, 2010    Key Record Dates
Last Update Posted: May 5, 2014
Last Verified: May 2014

Keywords provided by Astellas Pharma Inc:
Healthy Volunteers