A Phase1, Open-Label, Drug-Drug Interaction Study Between Methadone and Daclatasvir/Asunaprevir/BMS-791325 3 DAA FDC + 75mg BMS-791325 and Between Buprenorphine/Naloxone and Daclatasvir/Asunaprevir/BMS-791325 3 DAA FDC +75mg BMS-791325
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Maximum observed concentration (Cmax) of R-Methadone for Part 1
研究概览
简要总结
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.
详细描述
IND number: 101,943
Primary purpose: Other: Phase 1 Clinical Pharmacology drug interaction study in healthy subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must be on stable Methadone or Buprenorphine regimens for at least 28 days prior to screening
排除标准
- •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
研究组 & 干预措施
Part 1: Methadone + DCV 3DAA FDC + 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
干预措施: Methadone (Drug)
Part 1: Methadone + DCV 3DAA FDC + 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
干预措施: DCV 3DAA FDC (Drug)
Part 1: Methadone + DCV 3DAA FDC + 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
干预措施: BMS-791325 (Drug)
Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + 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
干预措施: DCV 3DAA FDC (Drug)
Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + 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
干预措施: BMS-791325 (Drug)
Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + 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
干预措施: Buprenorphine (Drug)
Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + 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
干预措施: Naloxone (Drug)
结局指标
主要结局
Maximum observed concentration (Cmax) of R-Methadone for Part 1
时间窗: 24 timepoints up to Day 13
Area under the concentration-time curve in one dosing interval (AUC(TAU)) of R-Methadone for Part 1
时间窗: 24 timepoints up to Day 13
Cmax of Buprenorphine and Norbuprenorphine for Part 2
时间窗: 24 timepoints up to Day 13
AUC(TAU) of Buprenorphine and Norbuprenorphine for Part 2
时间窗: 24 timepoints up to Day 13
次要结局
- 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)
- 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)