Relative Bioavailability of Zanubrutinib Tablets Compared to Capsules and Effects of Food on the Pharmacokinetics of the Tablet in Healthy Adults

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Zanubrutinib

• Registration Number: NCT05547399
• Lead Sponsor: BeiGene

Brief Summary

Study to assess the relative bioavailability of zanubrutinib tablets compared to capsules and to evaluate the effects of food on the pharmacokinetics (PK) of the zanubrutinib tablet.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-07
• Study First Submitted: 2022-09-16
• Study First Submitted QC: 2022-09-16
• Study First Posted: 2022-09-21
• Primary Completion: 2022-12-07
• Study Completion: 2022-12-07
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 signs measurements, and clinical laboratory evaluations as assessed by the investigator or designee
• Female participants of non-childbearing potential only

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) 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
• Use or intent to use prescription medications within 14 days prior to dosing or nonprescription medications/products/supplements within 7 days prior to check-in
• Use of tobacco or nicotine containing products within 3 months prior to check-in

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low Dose Cohort	Zanubrutinib	Zanubrutinib will be administered as a single low dose of treatment (tablet) or reference (capsule) on separate occasions across several treatment sequences
High Dose Cohort	Zanubrutinib	Zanubrutinib will be administered as a single high dose of treatment (tablet) or reference (capsule) on separate occasions across several treatment sequences

Primary Outcome Measures

Name	Time	Method
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 7
Apparent terminal elimination half-life (t1/2)	Predose and up to 48 hours postdose up to Day 7
Maximum observed plasma concentration (Cmax)	Predose and up to 48 hours postdose up to Day 7
Apparent oral clearance (CL/F)	Predose and up to 48 hours postdose up to Day 7
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 7
Time of the maximum observed plasma concentration (Tmax)	Predose and up to 48 hours postdose up to Day 7
Rate of decrease of concentration in the terminal phase (λz)	Predose and up to 48 hours postdose up to Day 7
Apparent volume of distribution (Vz/F)	Predose and up to 48 hours postdose up to Day 7

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events (AEs)	Up to approximately 6 months
Number of participants with clinically significant vital sign measurements	Up to approximately 6 months	Vital sign measurements include supine blood pressure, supine pulse rate, respiratory rate, and oral body temperature
Number of participants with clinically significant laboratory values	Up to approximately 6 months	Laboratory values are based on hematology, clinical chemistry, and urinalysis test results
Number of participants with clinically significant electrocardiogram (ECG) results	Up to approximately 6 months

Trial Locations

Locations (1)

Fortrea Clinical Research Unit; 🇺🇸 Dallas, Texas, United States