MedTrace Logo

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

NCT03432884 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-04-24

No results posted yet for this 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

Conditions

  • Healthy Volunteers

Interventions

DRUG

BGB-3111

Subjects will receive BGB-3111

DRUG

Placebo

Subjects will receive Placebo

DRUG

Moxifloxacin

Subjects will receive Moxifloxicin

Sponsors & Collaborators

  • BeiGene

    lead INDUSTRY

Principal Investigators

  • William Novotny, MD · BeiGene

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-25
Primary Completion
2018-04-16
Completion
2018-04-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03432884 on ClinicalTrials.gov