Drug Interaction & Methadone & Buprenorphine
Phase 1
Completed
- Conditions
- Hepatitis C
- Interventions
- Registration Number
- NCT02045693
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
IND number: 101,943
Primary purpose: Other: Phase 1 Clinical Pharmacology drug interaction study in healthy subjects
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
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 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: Methadone + DCV 3DAA FDC + BMS-791325 BMS-791325 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 Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + BMS-791325 BMS-791325 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 Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + BMS-791325 Naloxone 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 Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + BMS-791325 DCV 3DAA FDC 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 Part 1: Methadone + DCV 3DAA FDC + BMS-791325 DCV 3DAA FDC 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 Part 1: Methadone + DCV 3DAA FDC + BMS-791325 Methadone 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 Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + BMS-791325 Buprenorphine 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
- Primary Outcome Measures
Name Time Method AUC(TAU) of Buprenorphine and Norbuprenorphine for Part 2 24 timepoints up to Day 13 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
- Secondary Outcome Measures
Name Time Method 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 Tmax of Buprenorphine and Norbuprenorphine for Part 2 24 timepoints up to 13 days Ratio of metabolite AUC(TAU) to parent AUC(TAU) (MR_AUC(TAU)) of Norbuprenorphine to Buprenorphine 24 timepoints up to 13 days Cmax of of Daclatasvir (DCV) , Asunaprevir (ASV) , BMS-791325, and BMS-794712 10 timepoints on Day 12 AUC(TAU) of DCV, ASV, BMS-791325, and BMS-794712 10 timepoints on Day 12 Concentration at 12 hours (C12) of DCV, ASV, BMS-791325, and BMS-794712 10 timepoints on Day 12 Tmax of DCV, ASV, BMS-791325, and BMS-794712 10 timepoints on Day 12 MR_AUC(TAU) for BMS-794712 to BMS-791325 10 timepoints on Day 12 Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), death and AEs leading to discontinuation Up to day 13 Results of vital signs, Electrocardiograms (ECGs), Physical Examinations (PEs) and clinical labs Up to day 13 Scores of Clinical Opiate Withdrawal Scale (COWS), Subjective Opiate Withdrawal Scale (SOWS), Objective Opiate Withdrawal Scale (OOWS), and Opiate Overdose Assessment (OOA) Up to day 13
Trial Locations
- Locations (3)
Cri Lifetree
🇺🇸Philadelphia, Pennsylvania, United States
Anaheim Clinical Trials Llc
🇺🇸Anaheim, California, United States
Lifetree Clinical Research
🇺🇸Salt Lake City, Utah, United States