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

Phase 1

Completed

• Conditions: Healthy; Pharmacokinetics of ASP1585
• Interventions: Drug: ASP1585; Drug: 14C-Labeled ASP1585

• Registration Number: NCT01124747
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-04
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Study First Submitted: 2010-05-14
• Study First Submitted QC: 2010-05-14
• Study First Posted: 2010-05-17
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-02
• Last Update Posted: 2014-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ASP1585 and 14C-Labeled ASP1585	ASP1585	-
ASP1585 and 14C-Labeled ASP1585	14C-Labeled ASP1585	-

Primary Outcome Measures

Name	Time	Method
Excretion of radioactivity in urine	Day 15 and up to Day 24
Excretion of radioactivity in feces	Day 15 and up to Day 24

Secondary Outcome Measures

Name	Time	Method
Radioactivity assessment through analysis of blood samples	Day 15 and up to Day 24