Phase 1
Completed N=13
The Effect of Moderate CYP3A Inducer Rifabutin on the Pharmacokinetics of Zanubrutinib in Healthy Males
Healthy · Male
Source: ClinicalTrials.gov NCT04470908 ↗
Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcomePrimary: Area Under the Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Zanubrutinib — 2700; 1530 h*ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Zanubrutinib |
2700; 1530 | — |
| PRIMARY AUC From Time Zero to Infinity (AUC0-∞) of Zanubrutinib |
2780; 1590 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Zanubrutinib |
489; 253 | — |
| PRIMARY Time to the Maximum Observed Plasma Concentration (Tmax) of Zanubrutinib |
1.50; 2.00 | — |
| PRIMARY Time of the Last Quantifiable Concentration (Tlast) of Zanubrutinib |
36.0; 36.0 | — |
| PRIMARY Apparent Terminal Elimination Half-life (t1/2) of Zanubrutinib |
7.24; 7.00 | — |
| PRIMARY Apparent Oral Clearance (CL/F) of Zanubrutinib |
115; 201 | — |
| PRIMARY Apparent Volume of Distribution (Vz/F) of Zanubrutinib |
1080; 1750 | — |
| SECONDARY Number of Participants Experiencing Adverse Events (AEs) |
1; 6; 0; 0; 0; 0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Males of any race, between 18 and 65 years of age, inclusive.
- Male participants in good health as determined by past medical history, physical examination, vital signs, ECG and laboratory tests at screening
- Must have a body mass index (BMI) between 18 and 32 kg/m^2
Key Exclusion Criteria
- Participants with a clinically relevant history or presence of any clinically significant disease
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair will be allowed)
- History of drug or alcohol abuse within 1 year prior to check-in
- Use or intended use of any nonprescription medications/products including vitamins, minerals, herbal/plant-derived preparations within 7 days prior to check-in
- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result and/or a positive human immunodeficiency virus (HIV) at screening
- Use of tobacco- or nicotine-containing products within 3 months prior to check-in
- Use or intended use of any prescription medications/products within 14 days prior to check-in
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04470908). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.