Hepatitis C
Conditions
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
Interventions
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Cmax of S-Methadone and Total Methadone for Part 1 | 24 timepoints up to 13 days |
| 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 |
| Concentration at 12 hours (C12) of DCV, ASV, BMS-791325, and BMS-794712 | 10 timepoints on Day 12 |
| 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 |
Countries
United States
Outcome results
None listed