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EVRI

Phase 1

Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jul 31, 2008

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment17
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00578916Pharmacokinetics and Metabolism of Radiolabeled BMS-690514 in Healthy Male SubjectsPHASE1 COMPLETED 17Jan 1, 2008Jan 1, 2008Jul 31, 20081 Switzerland
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Study Endpoints
Primary Endpoints
Single dose pharmacokinetics of BMS-690514 and radioactivity in plasma and urine
measured for 10 days post-dose
Secondary Endpoints
Determination of biotransformation profiles and recorded adverse events
for 10 days post-dose
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
Interventions
NameTypeDescription
EVRI (BMS-690514)DRUGOral Solution, Oral, 200 mg, single dose followed by 10-12 day inpatient stay
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Eligibility Criteria
Age Range18 Years — 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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

Countries:Switzerland
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