Bioequivalence of a Zanubrutinib Tablet Compared to Capsules in Healthy Adult Participants

A Single-dose, Open-label, Randomized, Replicate Crossover Study in Healthy Adult Subjects to Assess the Bioequivalence of a Zanubrutinib Tablet Compared to Zanubrutinib Capsules

Study to determine the bioequivalence of a zanubrutinib tablet compared to capsules in healthy adult participants.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Zanubrutinib

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • Fortrea Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Body mass index between 18.0 and 32.0 kg/m^2, inclusive
• In good health, determined by no clinically significant findings from medical history, 12-lead ECGs, vital sign measurements, and clinical laboratory evaluations as assessed by the investigator or designee
• Female participants must be of non-childbearing potential (surgically sterile or postmenopausal)

Exclusion Criteria:

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator or designee
• Evidence of any infections (bacterial, viral, fungal, parasitic, COVID-19) within 4 weeks prior to the first dose of study drug, as determined by the investigator or designee
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator or designee
• History or presence of an abnormal ECG prior to the first dose of the study drug that, in the opinion of the investigator or designee, is clinically significant
• Abnormal liver function tests, as defined by aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin >upper limit of normal (ULN) range
• Positive hepatitis panel and/or positive human immunodeficiency virus test

Note: Other protocol defined Inclusion/Exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; Zanubrutinib will be administered as a single dose of treatment (tablet) or reference (capsule) on separate occasions.	Drug: Zanubrutinib; Administered as a tablet or capsule; Other Names: Brukinsa; BGB-3111
Experimental: Sequence 2; Zanubrutinib will be administered as a single dose of treatment (tablet) or reference (capsule) on separate occasions.	Drug: Zanubrutinib; Administered as a tablet or capsule; Other Names: Brukinsa; BGB-3111

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration (Cmax)	Predose and up to 48 hours postdose up to Day 10
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t)	Predose and up to 48 hours postdose up to Day 10
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)	Predose and up to 48 hours postdose up to Day 10
Time of the maximum observed plasma concentration (Tmax)	Predose and up to 48 hours postdose up to Day 10
Apparent terminal elimination half-life (t1/2)	Predose and up to 48 hours postdose up to Day 10
Apparent volume of distribution (Vz/F)	Predose and up to 48 hours postdose up to Day 10
Rate of decrease of concentration in the terminal phase (λz)	Predose and up to 48 hours postdose up to Day 10
Apparent oral clearance (CL/F)	Predose and up to 48 hours postdose up to Day 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events (AEs)		Up to 30 days after last dose; up to approximately 7 weeks
Number of participants with clinically significant laboratory values	Laboratory values are based on hematology, clinical chemistry, and urinalysis test results	Up to 30 days after last dose; up to approximately 7 weeks
Number of participants with clinically significant electrocardiogram (ECG) results		Up to 30 days after last dose; up to approximately 7 weeks
Number of participants with clinically significant vital sign measurements	Vital sign measurements include supine blood pressure, supine pulse rate, respiratory rate, and oral body temperature	Up to 30 days after last dose; up to approximately 7 weeks

Collaborators and Investigators

• Sponsor: BeiGene
• Investigators: Study Director: Study Director, BeiGene

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2023
• Primary Completion (Actual): April 28, 2023
• Study Completion (Actual): April 28, 2023

Study Registration Dates

• First Submitted: March 2, 2023
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 14, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2024
• Last Update Submitted That Met QC Criteria: October 23, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Tyrosine Kinase Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Zanubrutinib
• Other Study ID Numbers: BGB-3111-114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No