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Safety and Pharmacokinetics of Zanubrutinib (BGB-3111) in Healthy Subjects and Those With Impaired Liver Function

NCT03465059 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2020-04-24

No results posted yet for this study

Summary

This study is designed to evaluate the safety and pharmacokinetics of zanubrutinib in subjects with impaired liver function in comparison with healthy subjects

Conditions

  • Hepatic Insufficiency & Healthy Subjects

Interventions

DRUG

Zanubrutinib

A single oral dose of 80 mg Zanubrutinib will be administered.

Sponsors & Collaborators

  • BeiGene

    lead INDUSTRY

Principal Investigators

  • William Novotny, MD · BeiGene

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-30
Primary Completion
2018-10-19
Completion
2018-10-19
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 NCT03465059 on ClinicalTrials.gov