Drug Interaction & Methadone & Buprenorphine

NCT02045693 | Completed Phase 1

• 1 other identifier: AI443-108
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to assess the effects of steady state DCV/ASV/BMS-791325 fixed dose combination (FDC) + 75mg BMS-791325 on the Pharmacokinetics (PK) of Methadone in subjects with the stable dose of Methadone and on the PK of Buprenorphine in subjects with the stable dose of Buprenorphine.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (15)

• 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

• Time of maximum observed concentration (Tmax) of S-Methadone, Total Methadone and R-Methadone for Part 1

  24 timepoints up to 13 days

• C24 of Buprenorphine and Norbuprenorphine for Part 2

  24 timepoints up to 13 days

Study Arms (2)

Part 1: Methadone + DCV 3DAA FDC + BMS-791325

EXPERIMENTAL

Methadone 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

Drug: Methadone; Drug: DCV 3DAA FDC; Drug: BMS-791325

Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + BMS-791325

ACTIVE COMPARATOR

Buprenorphine/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

Drug: DCV 3DAA FDC; Drug: BMS-791325; Drug: Buprenorphine; Drug: Naloxone

Interventions

Methadone DRUG

Part 1: Methadone + DCV 3DAA FDC + BMS-791325

DCV 3DAA FDC DRUG

Part 1: Methadone + DCV 3DAA FDC + BMS-791325; Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + BMS-791325

BMS-791325 DRUG

Part 1: Methadone + DCV 3DAA FDC + BMS-791325; Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + BMS-791325

Buprenorphine DRUG

Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + BMS-791325

Naloxone DRUG

Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + BMS-791325

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be on stable Methadone or Buprenorphine regimens for at least 28 days prior to screening

You may not qualify if:

• Subjects must be healthy except for history of Methadone or Buprenorphine treatment regimens
• Prior exposure to DCV, ASV or BMS-791325 within 3 months of screening or any other investigational drug or placebo within 4 weeks of study drug administration

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (3)

Anaheim Clinical Trials Llc

Anaheim, California, 92801, United States

Location

Cri Lifetree

Philadelphia, Pennsylvania, 19139, United States

Location

Lifetree Clinical Research

Salt Lake City, Utah, 84106, United States

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Hepatitis C

Interventions

Methadone; 8-cyclohexyl-N-((dimethylamino)sulfonyl)-1,1a,2,12b-tetrahydro-11-methoxy-1a-((3-methyl-3,8-diazabicyclo(3.2.1)oct-8-yl)carbonyl)cycloprop(d)indolo(2,1-a)(2)benzazepine-5-carboxamide; Buprenorphine; Naloxone

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2014
• First Posted: January 27, 2014
• Study Start: February 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 17, 2014

Record last verified: 2014-06

Locations

US (3)