NCT07314346招募中1 期
A Phase 1, Open-Label, Two-Part, Single-Sequence Study to Evaluate the Effect of Multiple Oral Doses of BEM/RZR FDC on the Pharmacokinetics of Buprenorphine/Naloxone or Methadone in Participants on Stable Maintenance Therapy for Opiate Withdrawal
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Effect of BEM/RZR on PK of buprenorphine,norbuprenorphine and naloxone
研究概览
简要总结
Drug-drug interaction study between Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- •Must agree to use acceptable contraceptive methods through at least 90 days after the last dose of study drug.
- •Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/ m
- •Willing to comply with the study requirements and to provide written informed consent.
排除标准
- •Infected with hepatitis B virus, hepatitis C virus, HIV.
- •Abuse of alcohol or drugs.
- •Use of other investigational drugs within 28 days prior to Day -
- •Concomitant use of prescription medications, or systemic over-the-counter medications (apart from methadone or buprenorphine/naloxone as assigned maintenance therapy).
- •Other clinically significant medical conditions or laboratory abnormalities.
研究组 & 干预措施
(n=16) buprenorphine/naloxone + BEM/RZR
Experimental
干预措施: Buprenorphine/Naloxone + BEM/RZR (Drug)
(n=16) methadone + BEM/RZR
Experimental
干预措施: Methadone +BEM/RZR (Drug)
结局指标
主要结局
Effect of BEM/RZR on PK of buprenorphine,norbuprenorphine and naloxone
时间窗: Day -5 to Day 13
Cmax
Effect of BEM/RZR on PK of methadone
时间窗: Day -5 to Day 13
Cmax
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
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