CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 26 enrolled
Drug / intervention
Zanubrutinib +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04551963
NCT04551963Phase 1Completed
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A Drug-Drug Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Patients With B-Cell Malignancies

BeiGene·interventional·Posted Sep 16, 2020·Updated Oct 26, 2024

In Brief

A Phase 1 clinical trial evaluating Zanubrutinib, Fluconazole, and 3 other interventions for B-cell Malignancies. Completed, enrolled 26 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsB-cell Malignancies
CountriesAustralia
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedSep 16, 2020
Enrollment StartNov 15, 2020
Primary CompletionFeb 21, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 5.8 years ago

Interventions

Zanubrutinibdrug

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

Fluconazoledrug

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

Diltiazemdrug

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

Voriconazoledrug

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

Clarithromycindrug

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