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Methadone

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
ACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02045693Drug Interaction & Methadone & BuprenorphinePHASE1 COMPLETED 32Feb 1, 2014Apr 1, 2014Jun 17, 20143 United States
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Study Endpoints
Primary Endpoints
Maximum observed concentration (Cmax) of R-Methadone for Part 1
24 timepoints up to Day 13
Area under the concentration-time curve in one dosing interval (AUC(TAU)) of R-Methadone for Part 1
24 timepoints up to Day 13
Cmax of Buprenorphine and Norbuprenorphine for Part 2
24 timepoints up to Day 13
AUC(TAU) of Buprenorphine and Norbuprenorphine for Part 2
24 timepoints up to Day 13
Secondary Endpoints
Cmax of S-Methadone and Total Methadone for Part 1
24 timepoints up to 13 days
AUC(TAU) of S-Methadone and Total Methadone for Part 1
24 timepoints up to 13 days
Concentration at 24 hours (C24) of S-Methadone, Total Methadone and R-Methadone for Part 1
24 timepoints up to 13 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
Treatment Arms
ArmTypeDescription
Part 1: Methadone + DCV 3DAA FDC + BMS-791325EXPERIMENTALMethadone 40-120 mg tablet or solution orally once on Day 1 Methadone 40-120 mg tablet or solution orally once daily + DCV 3DAA FDC (Daclatasvir 30 mg/Asunaprevir 200 mg/BMS-791325 75 mg 3 direct-acting antiviral (3DAA) fixed dose combination tablet) orally twice daily + BMS-791325 75 mg tablet orally twice daily on Days 2 through 12
Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + BMS-791325ACTIVE_COMPARATORBuprenorphine/Naloxone 8/2 - 24/6 mg tablet or sublingual film orally once on Day 1 Buprenorphine/Naloxone 8/2 - 24/6 mg tablet or sublingual film orally once + DCV 3DAA FDC (Daclatasvir 30 mg/Asunaprevir 200 mg/BMS-791325 75 mg 3DAA fixed dose combination tablet) orally twice daily + BMS-791325 75 mg tablet orally twice daily on Days 2 through 12
Interventions
NameTypeDescription
MethadoneDRUG -
DCV 3DAA FDCDRUG -
BMS-791325DRUG -
BuprenorphineDRUG -
NaloxoneDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites3

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Subject must be on stable Methadone or Buprenorphine regimens for at least 28 days prior to screening Exclusion Criteria: * Subjects must be healthy except for history of M...

Countries:United States
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Competitive Landscape -Hepatitis C 11 trials