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BMS-562086

Phase 2

Irritable Bowel Syndrome | Small molecule | Gastrointestinal |Bristol-Myers Squibb Company|Last Updated: Sep 26, 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
RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment39
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00399438A Study of BMS-562086 in Patients With Irritable Bowel SyndromePHASE2 COMPLETED 39Dec 1, 2006Jan 1, 2008Sep 26, 20081 United States
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Study Endpoints
Primary Endpoints
Radioscintigraphy will be used to determine the effects of BMS-562086 on gastrointestinal transit
taken at baseline on nominal study days 3,4, and 5 and post dose on nominal study days 14,15, 16
Secondary Endpoints
Daily diary will be used to record the effects of BMS-562086 on bowel patterns and visceral symptoms.
throughout the study
Safety
Safety labs at screening, nominal study days -3, 8, 15, 42, and 70 (discharge). ECGs will be taken at screening, nominal days 5 or 6, 14, and discharge. Vital signs will be taken at screening, on nominal days 3, 4, 5, 7, 8, 10, 11, 42 and discharge
Blood pharmacokinetics
PK samples will be taken on nominal days 8, 14 (serial: predose 0.5, 1, 2, 4, 6, 9 hours post dose), 15 (pre dose and 9 hours post dose), 16, 42 and discharge
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
Treatment Arms
ArmTypeDescription
1OTHER0 mg
2OTHER25 mg
3OTHER100 mg
Interventions
NameTypeDescription
PlaceboDRUGTablets, Oral, once daily, 2 weeks
BMS-562086DRUGTablets, Oral, once daily, 2 weeks
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Eligibility Criteria
Age Range18 Years — 65 Years
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Female subjects with D-IBS symptoms based on Rome II criteria and the subject's responses to the Bowel Disease Questionnaire Exclusion Criteria: * Clinically significant prolonged diarrhea with dehydration requiring IV fluid within 60 days prior to baseline visit

Countries:United States
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