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BMS-650032

Phase 2

Chronic Hepatitis C | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Apr 27, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment335

FDA Designations

No designations recorded

Clinical trial landscape

BMS-650032 · 5 trials · 4 indications

Phase 2 3Phase 1 2
NCT01455090Study to Determine the Effectiveness and Safety of a Three Drug Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Not Previously Treated With Currently Available MedicationsChronic Hepatitis C
COMPLETED320 Analytics
NCT01030432Study of BMS-650032 With Peginterferon Alfa-2a Plus RibavirinHepatitis C Virus
COMPLETED285 Analytics
NCT00722358A Multiple Ascending Dose Study of BMS-650032 in HCV Infected SubjectsChronic Hepatitis C
COMPLETED15 Analytics
PHASE2COMPLETED
Study to Determine the Effectiveness and Safety of a Three Drug Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Not Previously Treated With Currently Available Medications
Chronic Hepatitis C
NCT01455090320
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PHASE2COMPLETED
Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin
Hepatitis C Virus
NCT01030432285
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PHASE2COMPLETED
A Multiple Ascending Dose Study of BMS-650032 in HCV Infected Subjects
Chronic Hepatitis C
NCT0072235815
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Study Endpoints

Primary Endpoints

Sustained virologic response (SVR) at 12 weeks post-treatment (SVR12)
12 weeks post-treatment
Phase 2a and Phase 2b: Safety, as measured by the frequency of SAEs and discontinuations due to AEs
12 weeks after first dose
Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA
Week 4
Phase 2b only: Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24), defined as undetectable HCV RNA
at follow-up Week 24
Antiviral activity will be assessed by the magnitude and rate of change in plasma HCV RNA levels from baseline. The primary endpoint for antiviral activity is decrease from baseline in plasma HCV RNA levels to Day 3/ or 5
To assess the change in HCV RNA during dosing with BMS-650032 from baseline to Day 3 and during follow-up period
Pharmacokinetics parameters including Cmax, Tmax,AUC(TAU),Vss/F, T-Half, CLT/F and AI
Day 10
Pharmacokinetic parameters including AUC (TAU) Cmax and Cmin
Day 21 pharmacokinetic assessment

Secondary Endpoints

Proportion of subjects with HCV ribonucleic acid (RNA) < limit of quantification (LOQ) (detectable and undetectable)
Weeks 1, 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22 and 24 weeks of therapy; at end of treatment (EOT) (following 12 or 24 weeks of treatment, by Group); and Weeks 4, 12, 24, 36, and 48 weeks post-treatment
Proportion of subjects with HCV ribonucleic acid (RNA) undetectable
Weeks 1, 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22 and 24 weeks of therapy; at end of treatment (EOT) (following 12 or 24 weeks of treatment, by Group); and Weeks 4, 12, 24, 36, and 48 weeks post-treatment
Proportion of subjects who experience viral breakthrough
Formal analysis at SVR12, Week 48 of follow up period (or upon occurrence)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group 1:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(75mg)EXPERIMENTALBMS-650032 200 mg tablet by mouth twice daily for 24 Weeks BMS-790052 60 mg tablet by mouth once daily for 24 Weeks BMS 791325 75 mg table by mouth twice daily for 24 Weeks
Group 2:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(75mg)EXPERIMENTALBMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 60 mg tablet by mouth once daily for 12 Weeks BMS 791325 75 mg table by mouth twice daily for 12 Weeks
Group 3:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(150mg)EXPERIMENTAL\* Contingent upon review of safety data from all available treated subjects from Groups 1 and 2 BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks BMS-790052 60 mg tablet by mouth once daily for 24 Weeks BMS 791325 150 mg table by mouth twice daily for 24 Weeks
Group 4:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(150mg)EXPERIMENTAL\* Contingent upon review of safety data from all available treated subjects from Groups 1 and 2 BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 60 mg tablet by mouth once daily for 12 Weeks BMS 791325 150 mg table by mouth twice daily for 12 Weeks
Group 5:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg)EXPERIMENTAL\* Genotype 1 treatment-naive subjects BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks BMS 791325 75 mg table by mouth twice daily for 12 Weeks
Group 6:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg)EXPERIMENTAL\* Genotype 1 treatment-naive subjects BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks BMS 791325 150 mg table by mouth twice daily for 12 Weeks
Group 7:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg)EXPERIMENTAL\* Genotype 4 treatment-naive subjects BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks BMS 791325 75 mg table by mouth twice daily for 12 Weeks
Group 8:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg)EXPERIMENTAL\* Genotype 4 treatment-naive subjects BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks BMS 791325 150 mg table by mouth twice daily for 12 Weeks
Group 9:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg)EXPERIMENTAL\* Genotype 1 treatment-null/non-responder subjects BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks BMS 791325 75 mg table by mouth twice daily for 12 Weeks
Group10:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg)EXPERIMENTAL\* Genotype 1 treatment-null/non-responder subjects BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks BMS 791325 150 mg table by mouth twice daily for 12 Weeks
Group11:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg)EXPERIMENTAL\* Genotype 1 treatment-null/non-responder subjects BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks BMS-790052 30 mg tablet by mouth twice daily for 24 Weeks BMS 791325 75 mg table by mouth twice daily for 24 Weeks
Group12:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg)EXPERIMENTAL\* Genotype 1 treatment-null/non-responder subjects BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks BMS-790052 30 mg tablet by mouth twice daily for 24 Weeks BMS 791325 150 mg table by mouth twice daily for 24 Weeks
Grp13:BMS-650032(200mg)+BMS-790052(30mg)+BMS-791325(75mg)+RBVEXPERIMENTAL\* Genotype 1 treatment-naive subjects BMS-650032 200 mg tablets orally twice daily 12 weeks BMS-790052 30 mg tablets orally twice daily 12 weeks BMS-791325 75 mg tablets orally twice daily 12 weeks Ribavirin (RBV) tablets orally weight based dosing daily 12 weeks \[if subject is \< 75 kg: 1000 mg per day orally (2 x 200 mg tablets in AM and 3 x 200 mg tablets in PM), or if ≥ 75 kg: 1200 mg per day orally (3 x 200 mg tablets in AM and 3 x 200 mg tablets in PM\]
Phase 2a: Arm 1EXPERIMENTAL -
Phase 2a: Arm 2PLACEBO_COMPARATOR -
Phase 2b: Arm 1EXPERIMENTAL -
Phase 2b: Arm 2PLACEBO_COMPARATOR -
BMS-650032ACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
BMS-650032 in Child-Pugh AACTIVE_COMPARATOR -
BMS-650032 in Child-Pugh BACTIVE_COMPARATOR -
BMS-650032 in Child-Pugh CACTIVE_COMPARATOR -
BMS-650032 in Healthy SubjectsACTIVE_COMPARATOR -
Treatment Group AEXPERIMENTAL -
Treatment Group BEXPERIMENTAL -
Treatment Group CEXPERIMENTALTreatment Groups A and B are followed by Treatment Group C: A combination of BMS-650032 (200 mg) and BMS-790052 (30 mg)

Interventions

NameTypeDescription
BMS-650032DRUG -
BMS-790052DRUG -
BMS-791325DRUG -
RibavirinDRUG -
PlaceboDRUGTablets, Oral, 0 mg, twice daily, 48 weeks
Peginterferon Alfa-2aDRUGSyringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites32

Inclusion Criteria: * Men and women, ages ≥18 years of age * Subjects who are naive to HCV treatment, defined as no previous exposure to an Interferon (IFN), Ribavirin (RBV); or any HCV-specific direct acting antiviral or experimental therapy or subjects who are null responders to previous pegylate...

Countries:United StatesFrancePuerto RicoArgentinaGermanyIrelandItalySpainUnited Kingdom
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Frequently asked questions about BMS-650032

What is BMS-650032 used for?

BMS-650032 is an investigational small molecule being studied for the treatment of chronic hepatitis C and hepatitis C virus infection. It has also been evaluated in clinical trials involving patients with hepatic insufficiency. The drug is in Phase 2 clinical development and is not yet approved by the FDA.

Who makes BMS-650032?

BMS-650032 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company has conducted clinical trials of BMS-650032 in the United States, Puerto Rico, and France.

What phase is BMS-650032 in?

BMS-650032 is in Phase 2 clinical development for chronic hepatitis C. It remains an investigational drug, meaning it has not received FDA approval and is still undergoing clinical trials to evaluate its safety and effectiveness in treating hepatitis C virus infection.

What clinical trials is BMS-650032 in?

BMS-650032 has been studied in several completed clinical trials. NCT00722358 was a multiple ascending dose study in HCV-infected subjects, NCT00904059 was a drug-drug interaction study in healthy subjects, NCT01019070 evaluated the drug in hepatically impaired subjects, and NCT01455090 tested a three-drug antiviral combination therapy in treatment-naive HCV patients.

Is BMS-650032 the same as asunaprevir?

BMS-650032 is the development code for asunaprevir, an investigational NS3 protease inhibitor. In clinical trials, it has been studied both as a monotherapy and in combination with other antiviral agents for the treatment of chronic hepatitis C virus infection.