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

BeiGene logo

BeiGene

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Moxifloxacin
Drug: Placebo
Drug: BGB-3111

Study type

Interventional

Funder types

Industry

Identifiers

NCT03432884
BGB-3111-106

Details and patient eligibility

About

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

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

40 participants in 3 patient groups, including a placebo group

Part A: BGB-3111
Experimental group
Treatment:
Drug: BGB-3111
Part A: Placebo
Placebo Comparator group
Treatment:
Drug: Placebo
Part B: BGB-3111, Placebo, and Moxifloxicin
Experimental group
Treatment:
Drug: Placebo
Drug: BGB-3111
Drug: Moxifloxacin

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems