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DCV 3DAA

Phase 1

Hepatitis C | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Oct 10, 2014

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
RandomizedCONTROLLEDBiomarker
Total Trials2
Total Enrollment65
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02095860Food Effect of a Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325PHASE1 COMPLETED 24 — — Apr 1, 2014May 1, 2014Oct 10, 20141 United States
NCT02108639To Assess the Effect of Renal Impairment on the Blood Levels of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325 After Multiple Doses of a Fixed Dose Combination TabletPHASE1 COMPLETED 41 — — Apr 1, 2014Jun 1, 2014Jul 10, 20144 United States
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Study Endpoints
Primary Endpoints
Maximum observed plasma concentration (Cmax) of DCV, ASV and BMS-791325
Day 1 to Day 13
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of DCV, ASV and BMS-791325
Day 1 to Day 13
Maximum observed plasma concentration (Cmax) for DCV, ASV, BMS-791325 and BMS-794712
For Groups A-D: Day 1 to Day 10 and for Group E: Day 1 to Day 12
Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) for DCV, ASV, BMS-791325 and BMS-794712
For Groups A-D: Day 1 to Day 10 and for Group E: Day 1 to Day 12
Secondary Endpoints
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] for DCV, ASV and BMS-791325
Day 1 to Day 13
Time of maximum observed plasma concentration (Tmax) for DCV, ASV and BMS-791325
Day 1 to Day 13
Terminal plasma half life (T-HALF) for DCV, ASV and BMS-791325
Day 1 to Day 13
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
Treatment A: DCV 3DAA FDC fasted stateEXPERIMENTALDCV 3 Direct Acting Antiviral (DAA) Fixed Dose Combination (FDC) tablet by mouth once on specified days in fasted state
Treatment B: DCV 3DAA FDC with high-fat mealEXPERIMENTALDCV 3DAA FDC tablet by mouth once on specified days with high-fat meal
Treatment C: DCV 3DAA FDC with light mealEXPERIMENTALDCV 3DAA FDC tablet by mouth once on specified days with light meal
DCV 3DAA FDC + BMS-791325EXPERIMENTALGroup A to D: DCV 3DAA FDC + BMS-791325 oral tablets on specific days Group E: DCV 3DAA FDC + BMS-791325 oral tablets on specific days
Interventions
NameTypeDescription
DCV 3DAA FDCDRUGFixed Dose Combination of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325
BMS-791325DRUG -
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Eligibility Criteria
Age Range18 Years — 49 Years
SexALL
Healthy VolunteersYes
Study Sites1

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Healthy male and female subjects ages 18 to 49 years, inclusive. * Women of childbearing potential must be using an acceptable method of contraception for at least 4 weeks pr...

Countries:United States
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Competitive Landscape -Hepatitis C 11 trials
CompanyTickerTrialsLead PhaseDrugs
Atea Pharmaceuticals, Inc.AVIR2PHASE3Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir
Abbott LaboratoriesABT2 — Undisclosed
AbbVie, Inc.ABBV1 — Undisclosed
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