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

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.

Timeline

Start

2020-11-15

Primary completion

2022-02-21

Completion

2022-02-21

Outcome

Mixed primary results

registry analysis (equivalence test); Arm A: Zanubrutinib With or Without Moderate CYP3A; Ratio of geometric least squares mean 0.94 (90% CI 0.82 to 1.08) NCT04551963 ↗

registry analysis (equivalence test); Arm A: Zanubrutinib With or Without Moderate CYP3A; Ratio of geometric least squares mean 0.49 (90% CI 0.42 to 0.56) NCT04551963 ↗

Publications

• Results Tariq B, Ou YC, Stern JC, Mundra V, Wong Doo N, Walker P, Lewis KL, Lin C, Novotny W, Sahasranaman S, Opat S. A phase 1, open-label, randomized drug-drug interaction study of zanubrutinib with moderate or strong CYP3A inhibitors in patients with B-cell malignancies. Leuk Lymphoma. 2023 Feb;64(2):329-338. doi: 10.1080/10428194.2022.2150820. Epub 2022 Dec 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Clarithromycin	Small molecule	250 mg	—
Subject	Diltiazem	Small molecule	180 mg	—
Subject	Fluconazole	Small molecule	400 mg	—
Subject	Voriconazole	Small molecule	200 mg	—
Subject	Zanubrutinib	Small molecule	80 mg	—
Subject	Zanubrutinib	Small molecule	160 mg	—
Subject	Zanubrutinib	Small molecule	320 mg	—

Indications