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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-25

Study Completion Date

2018-04-16

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Part A: Single Group Part B: Crossover

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Part A: zanubrutinib and placebo will be double-blind Part B: zanubrutinib and placebo will be double-blind; Moxifloxacin will be open-label

Study Groups

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Part A: BGB-3111

Group Type EXPERIMENTAL

BGB-3111

Intervention Type DRUG

Subjects will receive BGB-3111

Part A: Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subjects will receive Placebo

Part B: BGB-3111, Placebo, and Moxifloxicin

Group Type EXPERIMENTAL

BGB-3111

Intervention Type DRUG

Subjects will receive BGB-3111

Placebo

Intervention Type DRUG

Subjects will receive Placebo

Moxifloxacin

Intervention Type DRUG

Subjects will receive Moxifloxicin

Interventions

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BGB-3111

Subjects will receive BGB-3111

Intervention Type DRUG

Placebo

Subjects will receive Placebo

Intervention Type DRUG

Moxifloxacin

Subjects will receive Moxifloxicin

Intervention Type DRUG

Other Intervention Names

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Avelox

Eligibility Criteria

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Inclusion Criteria

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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes