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BMS-824393

Phase 1

Chronic Hepatitis C | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Jan 25, 2011

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment37
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00971308Multiple Dose Study In Treatment Naive Subjects Infected With Hepatitis C VirusPHASE1 COMPLETED 37 — — Oct 1, 2009Aug 1, 2010Jan 25, 20116 United States
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Study Endpoints
Primary Endpoints
Change from baseline in HCV RNA following three days of dosing with BMS-824393 in chronically genotype subtype 1a and 1b HCV infected subjects
On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration
Secondary Endpoints
To assess the change in HCV RNA over time during three days of dosing with BMS- 824393 and during the follow-up period in chronically genotype subtype 1a and 1b HCV infected subjects
On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration
To assess potential differences in antiviral effect in genotype subtypes (1a versus 1b)
On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration
To assess the safety and tolerability of multiple oral doses of BMS-824393
On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BMS-824393 (Panel 1)EXPERIMENTAL -
BMS-824393 (Panel 2)EXPERIMENTAL -
BMS-824393 (Panel 3)EXPERIMENTAL -
BMS-824393 (Panel 4)EXPERIMENTAL -
BMS-824393 (Panel 5)EXPERIMENTAL -
Interventions
NameTypeDescription
BMS-824393DRUGCapsule, Oral, 50mg, Once Daily, 3 days
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Treatment naive chronically infected subjects with Hepatitis C Virus genotype 1 * HCV RNA viral load of ≤10\*5\* IU/mL (100,000 IU/mL) * Body Mass Index (BMI) of 18 to 35 kg/m², inclusive Exclusion Criteria: * Women who are pregnant or breast feeding * Any significant acute ...

Countries:United States
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