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Cocktail

Phase 1

Hepatitis C | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Jun 17, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02045966Study to Determine the Potential DDIs When the Daclatasvir/Asunaprevir/BMS-791325 Three Drug Antiviral Combination Tablet (FDC) is Coadministered With a Cocktail of Cytochrome P450 (CYP) Probe Substrates and Transporter Probe Substrates (Digoxin and Pravastatin) in Healthy SubjectsPHASE1 COMPLETED 16Feb 1, 2014Apr 1, 2014Jun 17, 2014 -
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Study Endpoints
Primary Endpoints
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for each cocktail CYP and transporter probe substrate
51 time points up to day 36
Secondary Endpoints
Maximum observed concentration (Cmax) for each cocktail CYP and transporter probe substrate
51 time points up to day 36
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] for each cocktail CYP and transporter probe substrate
51 time points up to day 36
Cmax for the measured metabolites of the cocktail CYP and transporter probe substrates
51 time points up to day 36
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
Treatment Arms
ArmTypeDescription
Arm 1: Cocktail + DCV 3DAA FDC + BMS-791325EXPERIMENTALTreatment A: Cocktail of CYP and transporter probe substrates orally as a single dose on Day 1 Treatment B: DCV 3DAA FDC tablet administered orally BID on Days 6 to 15 Treatment C: DCV 3DAA FDC tablet administered orally BID on Days 16 to 20, plus the cocktail of CYP and transporter probe substrates administered orally as a single dose on Day 16 only Treatment D: DCV 3DAA FDC tablet plus BMS-791325 75-mg single-agent tablet administered orally BID on Days 21 to 30 Treatment E: DCV 3DAA FDC tablet plus BMS-791325 75-mg single-agent tablet administered orally BID on Days 31 to 35, plus the cocktail of CYP and transporter probe substrates administered orally as a single dose on Day 31 only
Interventions
NameTypeDescription
CocktailDRUGCocktail = Caffeine 200 mg, Metoprolol 50 mg, Montelukast 10 mg, Flurbiprofen 50 mg, Omeprazole 40 mg, Midazolam 5 mg, Digoxin 0.25 mg, and Pravastatin 40 mg
DCV 3DAA FDCDRUGDCV 30 mg + ASV 200 mg + BMS-791325 75 mg
BMS-791325DRUG -
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examinations, vital sign measurements, 12-lead ECG measurements...

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