BGB-3111-113: This phase I trial is trying to understand how the body reacts to a targeted therapy drug (zanubrutinib) with administered in combination with enzyme inhibitors (cytochrome P450 A) in people with B-Cell malignanciesA Drug-Drug Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Patients With B-Cell Malignancies

Summary

This is a randomised trial with two experimental arms. In Experimental Arm one, participants will receive zanzubrutinib in combination with moderate Cytochrome P450 A (CYP3A) inhibitors. Cycle 1 (28 days): Zanubrutinib 80 mg twice daily (BID) + fluconazole (days 4 - 10), zanubrutinib 320 mg once daily (QD) (days 13 - 19), zanubrutinib 80 mg BID + diltiazem (days 20 - 26) Cycles 2 - 6 (28 days each): zanubrutinib 160 mg BID or 320 mg QD. Zanubrutinib: 80 mg capsules administered at a dose and frequency as specified in the treatment arm. Fluconazole: 400 mg administered as 2 x 200 mg capsules once daily (QD). Diltiazem:180 mg capsule administered once daily (QD) In Experimental Arm two, participants will receive zanubrutinib + strong CYP3A. Cycle 1 (28 days): Zanubrutinib 80 mg QD + voriconazole (days 4 - 10), zanubrutinib 320 mg QD (days 13 - 19), zanubrutinib 80 mg QD + clarithromycin (days 20 - 26) Cycles 2 - 6 (28 days each): zanubrutinib 160 mg BID or 320 mg QD. Zanubrutinib: 80 mg capsules administered at a dose and frequency as specified in the treatment arm. Voriconazole: 200 mg capsules administered twice daily (BID). Clarithromycin: 250 mg capsules administered twice daily (BID)