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

NCT04551963 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-10-26

Study results available
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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

DRUG

Zanubrutinib

Capsules administered at a dose and frequency as specified in the treatment arm

DRUG

Fluconazole

Capsules administered at a dose and frequency as specified in the treatment arm

DRUG

Diltiazem

Capsules administered at a dose and frequency as specified in the treatment arm

DRUG

Voriconazole

Capsules administered at a dose and frequency as specified in the treatment arm

DRUG

Clarithromycin

Capsules administered at a dose and frequency as specified in the treatment arm

Sponsors & Collaborators

  • BeiGene

    lead INDUSTRY

Principal Investigators

  • Study Director · BeiGene

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-15
Primary Completion
2022-02-21
Completion
2022-02-21
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT04551963 on ClinicalTrials.gov