Trial · NCT04551963
Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Participants With B-Cell Malignancies
NCT04551963, Phase 1, Completed, BeiGene; results first posted 2023-11-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Participants With B-Cell Malignancies. Trials, record NCT04551963. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04551963
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Participants With B-Cell Malignancies
- NCT number
- NCT04551963
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 26 participants, actual
- Lead sponsor
- BeiGene
- Conditions
- B-cell Malignancies
- Interventions
- Zanubrutinib, Fluconazole, Diltiazem, Voriconazole, Clarithromycin
- First posted
- 2020-09-16
- Last updated
- 2024-10-26
- Results first posted
- 2023-11-27
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Arm A: Area Under Plasma Concentration-time Curve up to the Last Measurable Concentration (AUC0-t) | Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle) | |
| Primary | Arm B: Area Under Plasma Concentration-time Curve up to the Last Measurable Concentration (AUC0-t) | Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle) | |
| Primary | Arm A: Area Under Plasma Concentration-time Curve From Time 0 Extrapolated to 24 Hours (AUC0-24h) | Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle) | |
| Primary | Arm B: Area Under Plasma Concentration-time Curve From Time 0 Extrapolated to 24 Hours (AUC0-24h) | Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle) | |
| Primary | Arm A: Maximum Observed Concentration (Cmax) | Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle) | |
| Primary | Arm B: Maximum Observed Concentration (Cmax) | Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle) | |
| Primary | Arm A: Time of the Maximum Observed Concentration (Tmax) | Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle) | |
| Primary | Arm B: Time of the Maximum Observed Concentration (Tmax) | Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle) | |
| Primary | Arm A: Apparent Terminal Elimination Half-life (t1/2) | Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle) | |
| Primary | Arm B: Apparent Terminal Elimination Half-life (t1/2) | Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle) |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Arm A: Area Under Plasma Concentration-time Curve up to the Last Measurable Concentration (AUC0-t) | Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle) | 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). | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Arm B: Area Under Plasma Concentration-time Curve up to the Last Measurable Concentration (AUC0-t) | Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle) | 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). | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Arm A: Area Under Plasma Concentration-time Curve From Time 0 Extrapolated to 24 Hours (AUC0-24h) | Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle) | 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). | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Arm B: Area Under Plasma Concentration-time Curve From Time 0 Extrapolated to 24 Hours (AUC0-24h) | Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle) | 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). | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Arm A: Maximum Observed Concentration (Cmax) | Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle) | 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). | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Arm B: Maximum Observed Concentration (Cmax) | Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle) | 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). | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Arm A: Time of the Maximum Observed Concentration (Tmax) | Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle) | 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). | Hours | MEDIAN |
| PRIMARY | Arm B: Time of the Maximum Observed Concentration (Tmax) | Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle) | 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). | Hours | MEDIAN |
| PRIMARY | Arm A: Apparent Terminal Elimination Half-life (t1/2) | Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle) | 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). | Hours | GEOMETRIC_MEAN |
| PRIMARY | Arm B: Apparent Terminal Elimination Half-life (t1/2) | Predose, 0.5, 1, 2, 3, 4, 6, 8 and 10 hours on Cycle 1 Day 3, Day 10, and Day 28 (30-day cycle) | 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). | Hours | GEOMETRIC_MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Arm A: Area Under Plasma Concentration-time Curve up to the Last Measurable Concentration (AUC0-t) | Arm A: Zanubrutinib With or Without Moderate CYP3A | Zanubrutinib 320 mg QD | 1899.32 | Geometric Coefficient of Variation 44.95 | h*ng/mL |
| Arm A: Area Under Plasma Concentration-time Curve up to the Last Measurable Concentration (AUC0-t) | Arm A: Zanubrutinib With or Without Moderate CYP3A | Zanubrutinib 80 mg BID + 400 mg fluconazole QD | 921.63 | Geometric Coefficient of Variation 45.80 | h*ng/mL |
| Arm A: Area Under Plasma Concentration-time Curve up to the Last Measurable Concentration (AUC0-t) | Arm A: Zanubrutinib With or Without Moderate CYP3A | Zanubrutinib 80 mg BID + 180 mg diltiazem QD | 797.87 | Geometric Coefficient of Variation 43.05 | h*ng/mL |
| Arm B: Area Under Plasma Concentration-time Curve up to the Last Measurable Concentration (AUC0-t) | Arm B: Zanubrutinib With or Without Strong CYP3A | Zanubrutinib 320 mg QD | 1550.40 | Geometric Coefficient of Variation 49.20 | h*ng/mL |
| Arm B: Area Under Plasma Concentration-time Curve up to the Last Measurable Concentration (AUC0-t) | Arm B: Zanubrutinib With or Without Strong CYP3A | Zanubrutinib 80 mg QD + 200 mg voriconazole BID | 1254.29 | Geometric Coefficient of Variation 22.36 | h*ng/mL |
| Arm B: Area Under Plasma Concentration-time Curve up to the Last Measurable Concentration (AUC0-t) | Arm B: Zanubrutinib With or Without Strong CYP3A | Zanubrutinib 80 mg QD + 250 mg clarithromycin BID | 763.00 | Geometric Coefficient of Variation 54.79 | h*ng/mL |
| Arm A: Area Under Plasma Concentration-time Curve From Time 0 Extrapolated to 24 Hours (AUC0-24h) | Arm A: Zanubrutinib With or Without Moderate CYP3A | Zanubrutinib 320 mg QD | 2035.32 | Geometric Coefficient of Variation 46.97 | h*ng/mL |
| Arm A: Area Under Plasma Concentration-time Curve From Time 0 Extrapolated to 24 Hours (AUC0-24h) | Arm A: Zanubrutinib With or Without Moderate CYP3A | Zanubrutinib 80 mg BID + 400 mg fluconazole QD | 1911.93 | Geometric Coefficient of Variation 46.97 | h*ng/mL |
| Arm A: Area Under Plasma Concentration-time Curve From Time 0 Extrapolated to 24 Hours (AUC0-24h) | Arm A: Zanubrutinib With or Without Moderate CYP3A | Zanubrutinib 80 mg BID + 180 mg diltiazem QD | 1653.07 | Geometric Coefficient of Variation 44.88 | h*ng/mL |
| Arm B: Area Under Plasma Concentration-time Curve From Time 0 Extrapolated to 24 Hours (AUC0-24h) | Arm B: Zanubrutinib With or Without Strong CYP3A | Zanubrutinib 320 mg QD | 1578.12 | Geometric Coefficient of Variation 49.53 | h*ng/mL |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: Zanubrutinib With or Without Moderate CYP3A | 13 | |
| Overall Study | STARTED | Arm B: Zanubrutinib With or Without Strong CYP3A | 13 | |
| Overall Study | COMPLETED | Arm A: Zanubrutinib With or Without Moderate CYP3A | 11 | |
| Overall Study | COMPLETED | Arm B: Zanubrutinib With or Without Strong CYP3A | 12 | |
| Overall Study | NOT COMPLETED | Arm A: Zanubrutinib With or Without Moderate CYP3A | 2 | |
| Overall Study | NOT COMPLETED | Arm B: Zanubrutinib With or Without Strong CYP3A | 1 |
Source ClinicalTrials.gov
Adverse events42
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Rash | Skin and subcutaneous tissue disorders | Arm A: Zanubrutinib With or Without Moderate CYP3A | 1 | 13 | |
| other | Rash | Skin and subcutaneous tissue disorders | Arm B: Zanubrutinib With or Without Strong CYP3A | 2 | 13 | |
| other | Petechiae | Skin and subcutaneous tissue disorders | Arm A: Zanubrutinib With or Without Moderate CYP3A | 1 | 13 | |
| other | Petechiae | Skin and subcutaneous tissue disorders | Arm B: Zanubrutinib With or Without Strong CYP3A | 1 | 13 | |
| other | Constipation | Gastrointestinal disorders | Arm A: Zanubrutinib With or Without Moderate CYP3A | 1 | 13 | |
| other | Constipation | Gastrointestinal disorders | Arm B: Zanubrutinib With or Without Strong CYP3A | 3 | 13 | |
| other | Diarrhoea | Gastrointestinal disorders | Arm A: Zanubrutinib With or Without Moderate CYP3A | 0 | 13 | |
| other | Diarrhoea | Gastrointestinal disorders | Arm B: Zanubrutinib With or Without Strong CYP3A | 3 | 13 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Arm A: Zanubrutinib With or Without Moderate CYP3A | 0 | 13 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Arm B: Zanubrutinib With or Without Strong CYP3A | 2 | 13 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Zanubrutinib With or Without Moderate CYP3A | 1 | 13 |
| Total, all-cause mortality | Arm B: Zanubrutinib With or Without Strong CYP3A | 0 | 13 |
| Total, other adverse events | Arm A: Zanubrutinib With or Without Moderate CYP3A | 12 | 13 |
| Total, other adverse events | Arm B: Zanubrutinib With or Without Strong CYP3A | 12 | 13 |
| Total, serious adverse events | Arm A: Zanubrutinib With or Without Moderate CYP3A | 3 | 13 |
| Total, serious adverse events | Arm B: Zanubrutinib With or Without Strong CYP3A | 1 | 13 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36480811 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A: Zanubrutinib With or Without Moderate CYP3A vs Arm B: Zanubrutinib With or Without Strong CYP3A: deaths from any cause | Trial comparisons |
| Arm A: Zanubrutinib With or Without Moderate CYP3A vs Arm B: Zanubrutinib With or Without Strong CYP3A: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04551963
GET https://conductscience.org/api/trials/v1/NCT04551963/results?page=2