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

NCT01124747 | Completed Phase 1

• 1 other identifier: 1585-CL-0011
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Pharmacokinetics of ASP1585

Keywords

ASP1585; Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Radioactivity assessment through analysis of blood samples

  Day 15 and up to Day 24

Study Arms (1)

ASP1585 and 14C-Labeled ASP1585

EXPERIMENTAL

Drug: ASP1585; Drug: 14C-Labeled ASP1585

Interventions

ASP1585 DRUG

Oral

ASP1585 and 14C-Labeled ASP1585

14C-Labeled ASP1585 DRUG

Oral

ASP1585 and 14C-Labeled ASP1585

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Madison, Wisconsin, 53704, United States

Location

Study Officials

• Use Central Contact

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2010
• First Posted: May 17, 2010
• Study Start: April 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 5, 2014

Record last verified: 2014-05

Locations

US (1)