CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 13 enrolled
Drug / intervention
Zanubrutinib +1 moredrug
Likely dose
Zanubrutinib 320 mgfrom 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/NCT04470908
NCT04470908Phase 1Completed
CompareCT.gov

A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effect of the Moderate CYP3A Inducer Rifabutin on the Pharmacokinetics of Zanubrutinib in Healthy Male Subjects

BeiGene·interventional·Posted Jul 14, 2020·Updated Oct 26, 2024

In Brief

A Phase 1 clinical trial evaluating Zanubrutinib and Rifabutin for Healthy and Male. Completed, enrolled 13 participants across 1 site.

Detailed Summary

The primary objective of this study was to determine the effect of the moderate cytochrome P450 3A (CYP3A) inducer rifabutin on the pharmacokinetics (PK) of zanubrutinib in healthy males.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy, Male
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedJul 14, 2020
Enrollment StartJul 29, 2020
Primary CompletionNov 10, 2020
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.0 years ago

Interventions

Zanubrutinibdrug

Single oral dose of 320 mg

Rifabutindrug

Oral dose of 300 mg once daily