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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00578916
First received: December 19, 2007
Last updated: July 30, 2008
Last verified: July 2008
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Experimental: 1 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

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

ClinicalTrials.gov processed this record on July 28, 2014