A Phase 1, Open-Label, Multiple Dose Study to Evaluate the Drug-Drug Interaction Potential Between Bemnifosbuvir/Ruzasvir and Bictegravir/Emtricitabine/Tenofovir Alafenamide (Biktarvy®) in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- PK of Biktarvy (BIK: Bictegravir, tenofovir alafenamide, emtricitabine) on the pharmacokinetics (PK) of Bemnifosbuvir (BEM) and Ruzasvir (RZR).
研究概览
简要总结
Drug-drug interaction study of Biktarvy and Bemnifosbuvir/Ruzasvir
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug.
- •Minimum body weight of 50 kg and body mass index (BMI) of 18-30 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 or SARS-CoV-
- •Abuse of alcohol or drugs.
- •Use of other investigational drugs within 28 days of dosing.
- •Concomitant use of prescription medications, or systemic over-the-counter medications.
- •Other clinically significant medical conditions or laboratory abnormalities.
研究组 & 干预措施
BIK vs BEM/RZR + BIK vs BEM/RZR
n=14
干预措施: Cohort 2: Days 1-10 Biktarvy (BIK). Days 11-17 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered + Biktarvy (BIK). Days 18-24 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered. (Drug)
BEM/RZR vs BEM/RZR + BIK vs BIK
n=14
干预措施: Cohort 1: Days 1-7 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered. Days 8-17 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered + Biktarvy (BIK). Days 18-24 BIK (Drug)
结局指标
主要结局
PK of Biktarvy (BIK: Bictegravir, tenofovir alafenamide, emtricitabine) on the pharmacokinetics (PK) of Bemnifosbuvir (BEM) and Ruzasvir (RZR).
时间窗: Day 2, Days 4-7, Days 14-17, Days 21-24
Maximum plasma concentration (Cmax) and Area under the plasma concentration-time curve (AUC)
To determine the effect of Bemnifosbuvir (BEM)/Ruzasvir (RZR) combination on the PK of Biktarvy (BIK: Bictegravir, tenofovir alafenamide, emtricitabine)
时间窗: Days 7-10, Day 12, Days 14-17, Days 21-24.
Maximum plasma concentration (Cmax) and Area under the plasma concentration-time curve (AUC)
次要结局
未报告次要终点