NCT00578916

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1 cancer

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2007

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

July 31, 2008

Status Verified

July 1, 2008

Enrollment Period

Same day

First QC Date

December 19, 2007

Last Update Submit

July 30, 2008

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

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

    measured for 10 days post-dose

Secondary Outcomes (1)

  • Determination of biotransformation profiles and recorded adverse events

    for 10 days post-dose

Study Arms (1)

1

EXPERIMENTAL
Drug: EVRI (BMS-690514)

Interventions

EVRI (BMS-690514)DRUG

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

1

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Radiation exposure from diagnostic X-rays (except dental X-rays) in the last year or from clinical trials in the last 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Allschwil, 487 2401, Switzerland

Location

MeSH Terms

Conditions

Neoplasms

Interventions

BMS-690514

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 21, 2007

Study Start

January 1, 2008

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

July 31, 2008

Record last verified: 2008-07

Locations

CH(1)