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

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: EVRI (BMS-690514)

• Registration Number: NCT00578916
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-19
• Study First Posted: 2007-12-21
• Study Start: 2008-01
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-30
• Last Update Posted: 2008-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 17

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	EVRI (BMS-690514)	-

Primary Outcome Measures

Name	Time	Method
Single dose pharmacokinetics of BMS-690514 and radioactivity in plasma and urine	measured for 10 days post-dose

Secondary Outcome Measures

Name	Time	Method
Determination of biotransformation profiles and recorded adverse events	for 10 days post-dose

Trial Locations

Locations (1)

Local Institution; 🇨🇭 Allschwil, Switzerland