Clinical trial NCT05767398: Bioequivalence of a Zanubrutinib Tablet Compared to Capsules in Healthy Adult Participants
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2023-03-14
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Predose and up to 48 hours postdose up to Day 10
measure: Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t)
timeFrame: Predose and up to 48 hours postdose up to Day 10
measure: Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
timeFrame: Predose and up to 48 hours postdose up to Day 10
measure: Time of the maximum observed plasma concentration (Tmax)
timeFrame: Predose and up to 48 hours postdose up to Day 10
measure: Apparent terminal elimination half-life (t1/2)
timeFrame: Predose and up to 48 hours postdose up to Day 10
measure: Apparent volume of distribution (Vz/F)
timeFrame: Predose and up to 48 hours postdose up to Day 10
measure: Rate of decrease of concentration in the terminal phase (λz)
timeFrame: Predose and up to 48 hours postdose up to Day 10
measure: Apparent oral clearance (CL/F)
timeFrame: Predose and up to 48 hours postdose up to Day 10
Secondary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 30 days after last dose; up to approximately 7 weeks
measure: Number of participants with clinically significant laboratory values
timeFrame: Up to 30 days after last dose; up to approximately 7 weeks
measure: Number of participants with clinically significant electrocardiogram (ECG) results
timeFrame: Up to 30 days after last dose; up to approximately 7 weeks
measure: Number of participants with clinically significant vital sign measurements
timeFrame: Up to 30 days after last dose; up to approximately 7 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Fortrea Clinical Research Unit
state: Texas
Study officials:
affiliation: BeiGene
name: Study Director
role: STUDY_DIRECTOR
References: