CompletedNCT03432884Updated Apr 24, 2020

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

A Phase 1 interventional study of BGB-3111 and Placebo in Healthy Volunteers, sponsored by BeiGene. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-24.

Sponsored by BeiGene · Phase 1, Interventional, and Basic science

From the registry’s dates

Primary completion was Apr 2018, 8 years 6 months ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 40
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

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

Read the detailed description

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 studied

Healthy Volunteers

Keywords

Phase 1
pharmacokinetics
safety

In context

Lead sponsor

BeiGene is the lead sponsor of 125 studies on the registry; 2 are open to participants now.

Of its 54 completed or terminated interventional studies of FDA-regulated products, 32 (59%) have results posted.

Browse BeOne Medicines studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Eligibility criteria

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.

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 40 participants (actual)

Study arms

Experimental
Part A: BGB-3111
Drug: BGB-3111
Placebo comparator
Part A: Placebo
Drug: Placebo
Experimental
Part B: BGB-3111, Placebo, and Moxifloxicin
Drug: BGB-3111 · Drug: Placebo · Drug: Moxifloxacin

Interventions

DrugBGB-3111
Subjects will receive BGB-3111
DrugPlacebo
Subjects will receive Placebo
DrugMoxifloxacin
Subjects will receive Moxifloxicin
Also known as: Avelox

What researchers measure

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)
Incidence of treatment-emergent adverse events reported for zanubrutinib
Time frame: Up to 16 days

Study locations

1 site

Frontage Clinical Services, Inc.
Secaucus, New Jersey 07094, United States

References and documents

Publications

Mu S, Darpo B, Tang Z, Novotny W, Tawashi M, Xue H, Willett M, Lin L, Sahasranaman S, Ou YC. No QTc Prolongation With Zanubrutinib: Results of Concentration-QTc Analysis From a Thorough QT Study in Healthy Subjects. Clin Transl Sci. 2020 Sep;13(5):923-931. doi: 10.1111/cts.12779. Epub 2020 Apr 8. PubMed 32144955 ↗

Individual participant data

Plan to share: Undecided

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2018 to primary completion in Apr 2018, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered: Jan 19, 2018
First posted: Feb 14, 2018
StartActual: Jan 25, 2018
Primary completionActual: Apr 16, 2018
CompletionActual: Apr 16, 2018
Last update: Apr 24, 2020

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Apr 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03432884
Lead sponsor: BeiGene
Responsible party: Sponsor
First posted: Feb 14, 2018
Start date: Jan 25, 2018
Primary completion: Apr 16, 2018
Completion: Apr 16, 2018
Last update: Apr 24, 2020

Study contacts

William Novotny, MD

study director · BeiGene

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Zanubrutinib · Moxifloxacin

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