NCT00437437

A Phase I Study to Determine the Effect of Food on Brivanib (BMS-582664)

Phase I Study to Determine the Effect of a High Fat Meal on the Pharmacokinetics of BMS-540215, the Active Metabolite of Brivanib Alaninate in Subjects With Advanced or Metastatic Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to determine the effect of food versus a fasted state on single-dose pharmacokinetics of BMS-540215, the active metabolite of Brivanib alaninate

Conditions

• Tumors

Interventions

Type	Name	Description
DRUG	Brivanib	Tablet, Oral, Brivanib 800 mg, QD after single dose Pk comparison of food effect, until progression

Timeline

• Start date: 2000-05-01
• Primary completion: 2008-05-01
• Completion: 2013-02-01
• First posted: 2007-02-21
• Last updated: 2013-06-21

Locations

3 sites across 1 country: United States