NCT03432884

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

January 25, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 14, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2018

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

3 months

First QC Date

January 19, 2018

Last Update Submit

April 22, 2020

Conditions

Healthy Volunteers

Keywords

Phase 1pharmacokineticssafety

Outcome Measures

Primary Outcomes (2)

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

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

    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

    Up to 2 days

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (3)

Part A: BGB-3111

EXPERIMENTAL
Drug: BGB-3111

Part A: Placebo

PLACEBO COMPARATOR
Drug: Placebo

Part B: BGB-3111, Placebo, and Moxifloxicin

EXPERIMENTAL
Drug: BGB-3111Drug: PlaceboDrug: Moxifloxacin

Interventions

BGB-3111DRUG

Subjects will receive BGB-3111

Part A: BGB-3111Part B: BGB-3111, Placebo, and Moxifloxicin
PlaceboDRUG

Subjects will receive Placebo

Part A: PlaceboPart B: BGB-3111, Placebo, and Moxifloxicin
MoxifloxacinDRUG

Subjects will receive Moxifloxicin

Also known as: Avelox
Part B: BGB-3111, Placebo, and Moxifloxicin

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Frontage Clinical Services, Inc.

Secaucus, New Jersey, 07094, United States

Location

Related Publications (1)

  • 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.

    PMID: 32144955RESULT

MeSH Terms

Interventions

zanubrutinibMoxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • William Novotny, MD

    BeiGene

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Part A: zanubrutinib and placebo will be double-blind Part B: zanubrutinib and placebo will be double-blind; Moxifloxacin will be open-label
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Part A: Single Group Part B: Crossover
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2018

First Posted

February 14, 2018

Study Start

January 25, 2018

Primary Completion

April 16, 2018

Study Completion

April 16, 2018

Last Updated

April 24, 2020

Record last verified: 2020-04

Locations

US(1)