A Two-Part Study Consisting of a Randomized, Placebo-Controlled, Single Dose Safety and Tolerability Study (Part A) Evaluating a Supratherapeutic Dose of Zanubrutinib Followed by a Randomized, Placebo- and Positive-Controlled, Crossover Study (Part B) to Evaluate the Effect of Zanubrutinib on Cardiac Repolarization in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Part A: Incidence of treatment-emergent adverse events (safety and tolerability)
研究概览
简要总结
A Two-Part Phase 1 Study to Investigate A) Safety and Tolerability of Supratherapeutic dose of Zanubrutinib (BGB-3111) and B) Effect of Zanubrutinib on Cardiac Repolarization in Healthy Subjects
详细描述
This is a Two-Part Phase 1 Study.
Part A: This is a randomized, placebo-controlled, double blind, single dose study to evaluate the safety and tolerability of a single oral supratherapeutic dose of zanubrutinib in eight (8) subjects.
Part B: This is a randomized, placebo and positive-controlled, double-blind, 4-way crossover study being conducted in about 28 subjects to investigate the effect of a single therapeutic dose of zanubrutinib, a supratherapeutic dose of zanubrutinib and placebo on cardiac repolarization. Open-label Moxifloxacin (400 mg), a fluoroquinolone broad spectrum antibiotic will be used as a positive control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Part A: zanubrutinib and placebo will be double-blind Part B: zanubrutinib and placebo will be double-blind; Moxifloxacin will be open-label
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
- •All subjects
- •Body mass index (BMI) 18 - 33 kg/m2, inclusive.
- •In good general health as assessed by the Investigator.
- •Females of non-child bearing potential.
- •Males without a vasectomy will agree to use required barrier contraception, and will agree to not donate sperm from the time of the first dose of BGB-3111 until ≥ 90 days after the last dose of BGB-
- •Able to comprehend and willing to sign consent.
排除标准
- •All subjects
- •Subjects with a clinically relevant history or presence of any clinically significant disease.
- •Personal or known family history of congenital or acquired long QT syndrome or cardiovascular disease.
- •Women of child-bearing potential.
- •History of alcoholism or drug/chemical abuse within 6 months.
研究组 & 干预措施
Part B: BGB-3111, Placebo, and Moxifloxicin
干预措施: Placebo (Drug)
Part A: BGB-3111
干预措施: BGB-3111 (Drug)
Part A: Placebo
干预措施: Placebo (Drug)
Part B: BGB-3111, Placebo, and Moxifloxicin
干预措施: BGB-3111 (Drug)
Part B: BGB-3111, Placebo, and Moxifloxicin
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Part A: Incidence of treatment-emergent adverse events (safety and tolerability)
时间窗: Up to 8 days
Incidence of treatment-emergent adverse events reported for zanubrutinib compared with placebo
Part B: Corrected QT interval [QTc]
时间窗: Up to 2 days
Evaluate the effects of single doses of zanubrutinib on the corrected QT interval \[QTc\] using the Fridericia correction \[QTcF\]) compared with placebo
次要结局
- Part B: Incidence of treatment-emergent adverse events (safety and tolerability)(Up to 16 days)
- Part A: PK Parameters(Up to 3 days)
- Part B: Heart Rate (HR)(Up to 2 days)
- Part B: PR Intervals(Up to 2 days)
- Part B: QRS Intervals(Up to 2 days)
- Part B: PK Parameters(Up to 2 days)