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Pharmacokinetics and Metabolism of Radiolabeled BMS-690514 in Healthy Male Subjects
This study has been completed.
Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00578916
  Purpose

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


Condition Intervention Phase
Cancer
 Drug: EVRI (BMS-690514)
 Phase I

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title: Pharmacokinetics and Metabolism of [14C] BMS-690514 in Healthy Male Subjects

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Single dose pharmacokinetics of BMS-690514 and radioactivity in plasma and urine [ Time Frame: measured for 10 days post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determination of biotransformation profiles and recorded adverse events [ Time Frame: for 10 days post-dose ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: January 2008
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: EVRI (BMS-690514)
Oral Solution, Oral, 200 mg, single dose followed by 10-12 day inpatient stay

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00578916

Locations
Switzerland
Local Institution
Allschwil, Switzerland, 487 2401
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

Responsible Party: Bristol-Myers Squibb ( Study Director )
Study ID Numbers: CA187-003
Study First Received: December 19, 2007
Last Updated: July 30, 2008
ClinicalTrials.gov Identifier: NCT00578916  
Health Authority: Switzerland: Swissmedic;   Switzerland: Ethikkommission

Study placed in the following topic categories:
Healthy

ClinicalTrials.gov processed this record on January 16, 2009



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