A Two-Part Phase 1 Study to Investigate the Safety and Tolerability of Supratherapeutic Dose of Zanubrutinib and Effect of Zanubrutinib on Cardiac Repolarization in Healthy Subjects

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.

Inclusion criteria

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-3111.
• Able to comprehend and willing to sign consent.

Exclusion criteria

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.