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Completed

NCT Number: NCT00578916

Pharmacokinetics and Metabolism of Radiolabeled 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.

Completed

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Key information

Conditions

Cancer Neoplasms

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Allschwil, 487 2401, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EVRI (BMS-690514)

Drug

Oral Solution, Oral, 200 mg, single dose followed by 10-12 day inpatient stay

Primary outcomes

  1. Single dose pharmacokinetics of BMS-690514 and radioactivity in plasma and urine

    Time frame: measured for 10 days post-dose

Secondary outcomes

  1. Determination of biotransformation profiles and recorded adverse events

    Time frame: for 10 days post-dose

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Dec 21, 2007
Registry last updated
Jul 31, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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