Pharmacokinetics and Metabolism of Radiolabeled BMS-690514 in Healthy Male Subjects

July 30, 2008 updated by: Bristol-Myers Squibb

Pharmacokinetics and Metabolism of [14C] BMS-690514 in Healthy Male Subjects

The purpose of this study is to determine how the human body processes and eliminates the drug (BMS-690514.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Allschwil, Switzerland, 487 2401
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male subjects
  • Body mass index (BMS) of 18 - 30 kg/m², inclusive

Exclusion Criteria:

  • Radiation exposure from diagnostic X-rays (except dental X-rays) in the last year or from clinical trials in the last 5 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: EVRI (BMS-690514)
Oral Solution, Oral, 200 mg, single dose followed by 10-12 day inpatient stay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Single dose pharmacokinetics of BMS-690514 and radioactivity in plasma and urine
Time Frame: measured for 10 days post-dose
measured for 10 days post-dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Determination of biotransformation profiles and recorded adverse events
Time Frame: for 10 days post-dose
for 10 days post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

December 19, 2007

First Submitted That Met QC Criteria

December 19, 2007

First Posted (Estimate)

December 21, 2007

Study Record Updates

Last Update Posted (Estimate)

July 31, 2008

Last Update Submitted That Met QC Criteria

July 30, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Other Study ID Numbers

  • CA187-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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