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

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Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers

Interventions

BGB-3111DRUG

Subjects will receive BGB-3111

PlaceboDRUG

Subjects will receive Placebo

MoxifloxacinDRUG

Subjects will receive Moxifloxicin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: All subjects 1. Body mass index (BMI) 18 - 33 kg/m2, inclusive. 2. In good general health as assessed by the Investigator. 3. Females of non-child bearing potential. 4. 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. 5. Able to comprehend and willing to sign consent. Exclusion Criteria: All subjects 1. Subjects with a clinically relevant history or presence of any clinically significant disease. 2. Personal or known family history of congenital or acquired long QT syndrome or cardiovascular disease. 3. Women of child-bearing potential. 4. History of alcoholism or drug/chemical abuse within 6 months.

Locations (1)

Frontage Clinical Services, Inc.

Secaucus, New Jersey, United States

Outcomes

Primary Outcomes

Part A: Incidence of treatment-emergent adverse events (safety and tolerability)

Incidence of treatment-emergent adverse events reported for zanubrutinib compared with placebo

Time frame: Up to 8 days

Part B: Corrected QT interval [QTc]

Evaluate the effects of single doses of zanubrutinib on the corrected QT interval \[QTc\] using the Fridericia correction \[QTcF\]) compared with placebo

Time frame: Up to 2 days

Secondary Outcomes

Part A: PK Parameters

Plasma concentrations of zanubrutinib to evaluate protocol specified PK parameters

Time frame: Up to 3 days

Part B: Heart Rate (HR)

Evaluate the effects of a single dose of zanubrutinib and a single supratherapeutic dose of zanubrutinib on heart rate (HR)

Time frame: Up to 2 days

Part B: PR Intervals

Evaluate the effects of a single dose of zanubrutinib and a single supratherapeutic dose of zanubrutinib on PR

Time frame: Up to 2 days

Part B: QRS Intervals

Evaluate the effects of a single dose of zanubrutinib and a single supratherapeutic dose of zanubrutinib on QRS Intervals

Time frame: Up to 2 days

Part B: PK Parameters

Plasma concentrations of zanubrutinib to evaluate protocol specified PK parameters

Time frame: Up to 2 days

Part B: Incidence of treatment-emergent adverse events (safety and tolerability)

Data from ClinicalTrials.gov

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