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Methadone

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

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

Methadone · 1 trial · 1 indication

Phase 1 1
NCT02045693Drug Interaction & Methadone & BuprenorphineHepatitis C
COMPLETED32 Analytics
PHASE1COMPLETED
Drug Interaction & Methadone & Buprenorphine
Hepatitis CUnlock trial analytics

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 to 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

Frequently asked questions about Methadone

What is Methadone used for in Hepatitis C?

Methadone is being studied for use in Hepatitis C as part of a Phase 1 clinical trial. The trial, NCT02045693, is a drug interaction study involving Methadone and Buprenorphine in healthy volunteers. It is an active-controlled, non-randomized study that has been completed with 32 participants in the United States.

Who makes Methadone?

Methadone is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company is conducting research on Methadone for the treatment of Hepatitis C, an infectious disease. The drug is a small molecule therapeutic currently in Phase 1 clinical development.

What phase is Methadone in?

Methadone is in Phase 1 clinical development for Hepatitis C. It is an investigational drug and has not been approved by the FDA. The Phase 1 trial, NCT02045693, has been completed, and it involved 32 participants. The study was conducted in the United States and included healthy volunteers.

What clinical trials is Methadone in?

Methadone has one completed clinical trial, NCT02045693, titled "Drug Interaction & Methadone & Buprenorphine." This Phase 1 study enrolled 32 participants with Hepatitis C and was conducted in the United States. The trial was active-controlled and included healthy volunteers aged 18 years and older.

Is Methadone the same as Buprenorphine?

No, Methadone is not the same as Buprenorphine. They are distinct drugs. However, they are being studied together in a clinical trial, NCT02045693, to assess drug interactions. This Phase 1 study is investigating their combined effects in the context of Hepatitis C treatment.