Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Antihypertensive Agents

Channel Blockers

Vasodilator Agents

Bone Density Conservation Agents

Amino Acids

Zanubrutinib

Clarithromycin

Voriconazole

Fluconazole

Diltiazem

Cytochrome P-450 CYP3A Inhibitors

Anti-Bacterial Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Clotrimazole

Miconazole

Antifungal Agents

Hormones

Hormone Antagonists

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Calcium

Calcium Channel Blockers

Calcium, Dietary

Tyrosine

Cycle 1 (30 days): Participants were administered zanubrutinib at a dose of 320 mg once a day from Day 1 to Day 3; From Day 4 to Day 10, fluconazole was administered once a day at a dose of 400 mg with zanubrutinib at a reduced dose of 80 mg twice a day; On Day 11 and Day 12, zanubrutinib monotherapy was administered at 80 mg twice a day, followed by 320 mg once a day from Day 13 to Day 21; From Day 22 to Day 28, diltiazem was administered once a day at a dose of 180 mg with 80 mg zanubrutinib twice a day; On Day 29 and Day 30, zanubrutinib monotherapy was administered 80 mg twice a day.

Cycles 2 to 6 (28 days each cycle): Zanubrutinib 160 mg twice a day or 320 mg once a day.

Cycle 1 (30 days): Participants were administered zanubrutinib at a dose of 320 mg once a day from Day 1 to Day 3; From Day 4 to Day 10, voriconazole was administered twice a day at a dose of 200 mg (total daily dose of 400 mg) with zanubrutinib at a reduced dose of 80 mg once a day; On Day 11 and Day 12, zanubrutinib monotherapy was administered at 80 mg once a day, followed by 320 mg once a day from Day 13 to Day 21; From Day 22 to Day 28, clarithromycin was administered twice a day at a dose of 250 mg (total daily dose of 500 mg) with 80 mg zanubrutinib once a day; On Day 29 and Day 30, zanubrutinib monotherapy was administered 80 mg once a day.

Cycles 2 to 6 (28 days each cycle): Zanubrutinib 160 mg twice a day or 320 mg once a day.

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

Study Director

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.

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

A Drug-Drug Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Patients With B-Cell Malignancies

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including clinical laboratory tests

BeiGene

The safety analysis set included all participants who were enrolled and received any dose of zanubrutinib

Arm A: Zanubrutinib With or Without Moderate CYP3A

Arm B: Zanubrutinib With or Without Strong CYP3A

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Arm A: Zanubrutinib alone vs. Zanubrutinib + fluconazole

Arm a: Zanubrutinib alone vs. Zanubrutinib + diltiazem

Zanubrutinib 320 mg QD

Zanubrutinib 80 mg BID + 400 mg fluconazole QD

Zanubrutinib 80 mg BID + 180 mg diltiazem QD

Cycle 1 (30 days): Participants were administered zanubrutinib at a dose of 320 mg once a day (QD) from Day 1 to Day 3; From Day 4 to Day 10, fluconazole was administered once a day at a dose of 400 mg with zanubrutinib at a reduced dose of 80 mg twice a day (BID); On Day 11 and Day 12, zanubrutinib monotherapy was administered at 80 mg twice a day, followed by 320 mg once a day from Day 13 to Day 21; From Day 22 to Day 28, diltiazem was administered once a day at a dose of 180 mg with 80 mg zanubrutinib twice a day; On Day 29 and Day 30, zanubrutinib monotherapy was administered 80 mg twice a day.

Cycles 2 to 6 (28 days each cycle): Zanubrutinib 160 mg twice a day or 320 mg once a day.

The pharmacokinetic (PK) analysis set included all participants who received at last 1 dose of zanubrutinib and had evaluable PK data (at least 1 PK parameter could be calculated).

Arm A: Area Under Plasma Concentration-time Curve up to the Last Measurable Concentration (AUC0-t)

Arm B: Zanubrutinib alone vs. zanubrutinib + voriconazole

Arm B: Zanubrutinib alone vs zanubrutinib + clarithromycin

Zanubrutinib 80 mg QD + 200 mg voriconazole BID

Zanubrutinib 80 mg QD + 250 mg clarithromycin BID

Cycle 1 (30 days): Participants were administered zanubrutinib at a dose of 320 mg once a day from Day 1 to Day 3; From Day 4 to Day 10, voriconazole was administered twice a day at a dose of 200 mg (total daily dose of 400 mg) with zanubrutinib at a reduced dose of 80 mg once a day; On Day 11 and Day 12, zanubrutinib monotherapy was administered at 80 mg once a day, followed by 320 mg once a day from Day 13 to Day 21; From Day 22 to Day 28, clarithromycin was administered twice a day at a dose of 250 mg (total daily dose of 500 mg) with 80 mg zanubrutinib once a day; On Day 29 and Day 30, zanubrutinib monotherapy was administered 80 mg once a day.

The PK analysis set included all participants who received at last 1 dose of zanubrutinib and had evaluable PK data (at least 1 PK parameter could be calculated).

Arm B: Area Under Plasma Concentration-time Curve up to the Last Measurable Concentration (AUC0-t)

Arm A: Zanubrutinib alone vs. zanubrutinib + fluconazole

Arm A: Zanubrutinib alone vs. zanubrutinib + diltiazem

Spots Global Cancer Trial Database for Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Participants With B-Cell Malignancies

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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