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Cocktail

Phase 1

Hepatitis C | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Jun 17, 2014

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

Cocktail · 1 trial · 1 indication

Phase 1 1
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 SubjectsHepatitis C
COMPLETED16 Analytics
PHASE1COMPLETED
Study 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 Subjects
Hepatitis CUnlock trial analytics

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 to 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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Competitive Landscape -Hepatitis C 11 trials

Frequently asked questions about Cocktail

What is Cocktail used for in Hepatitis C?

Cocktail is an investigational small molecule combination being studied for Hepatitis C. It combines daclatasvir, asunaprevir, and BMS-791325 in a fixed-dose tablet. The drug is in Phase 1 clinical development and is not approved by the FDA.

Who makes Cocktail?

Cocktail is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company is conducting clinical trials to evaluate the drug for the treatment of Hepatitis C.

What phase is Cocktail in?

Cocktail is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed to assess the drug's potential interactions with other medications.

What clinical trials is Cocktail in?

Cocktail has one completed clinical trial, NCT02045966. This Phase 1 study evaluated the drug interactions when the daclatasvir, asunaprevir, and BMS-791325 combination tablet is coadministered with a cocktail of cytochrome P450 probe substrates and transporter probe substrates in healthy subjects.

Is Cocktail the same as a daclatasvir, asunaprevir, and BMS-791325 combination?

Yes, Cocktail refers to a fixed-dose combination tablet containing daclatasvir, asunaprevir, and BMS-791325. This three-drug antiviral combination is being studied for Hepatitis C. The clinical trial NCT02045966 specifically evaluates this combination tablet.