Clinical Trials Directory

Trials / Completed

CompletedNCT04551963

Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Participants With B-Cell Malignancies

A Drug-Drug Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Patients With B-Cell Malignancies

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
26 (actual)
Sponsor
BeiGene · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The primary objective of this study was to assess the steady-state zanubrutinib pharmacokinetics (PK) when co-administered with moderate and strong cytochrome P450 family 3 subfamily A (CYP3A) inhibitors.

Conditions

Interventions

TypeNameDescription
DRUGZanubrutinibCapsules administered at a dose and frequency as specified in the treatment arm
DRUGFluconazoleCapsules administered at a dose and frequency as specified in the treatment arm
DRUGDiltiazemCapsules administered at a dose and frequency as specified in the treatment arm
DRUGVoriconazoleCapsules administered at a dose and frequency as specified in the treatment arm
DRUGClarithromycinCapsules administered at a dose and frequency as specified in the treatment arm

Timeline

Start date
2020-11-15
Primary completion
2022-02-21
Completion
2022-02-21
First posted
2020-09-16
Last updated
2024-10-26
Results posted
2023-11-27

Locations

7 sites across 1 country: Australia

Regulatory

Source: ClinicalTrials.gov record NCT04551963. Inclusion in this directory is not an endorsement.