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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05767398
• Other study ID #: BGB-3111-114
• Status: Completed
• Phase: Phase 1
• Start date: March 7, 2023
• Est. completion date: April 28, 2023

Study information

• Verified date: July 2023
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: April 28, 2023
• Est. primary completion date: April 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Zanubrutinib
Administered as a tablet or capsule

Locations

Country	Name	City	State
United States	Labcorp Clinical Research Unit Inc.	Dallas	Texas
United States	Labcorp Clinical Research Unit Inc.	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax)		Predose and up to 48 hours postdose up to Day 10
Primary	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
Primary	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
Primary	Time of the maximum observed plasma concentration (Tmax)		Predose and up to 48 hours postdose up to Day 10
Primary	Apparent terminal elimination half-life (t1/2)		Predose and up to 48 hours postdose up to Day 10
Primary	Apparent volume of distribution (Vz/F)		Predose and up to 48 hours postdose up to Day 10
Primary	Rate of decrease of concentration in the terminal phase (?z)		Predose and up to 48 hours postdose up to Day 10
Primary	Apparent oral clearance (CL/F)		Predose and up to 48 hours postdose up to Day 10
Secondary	Number of participants with adverse events (AEs)		Up to 30 days after last dose; up to approximately 7 weeks
Secondary	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
Secondary	Number of participants with clinically significant electrocardiogram (ECG) results		Up to 30 days after last dose; up to approximately 7 weeks
Secondary	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