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

Healthy Volunteers Clinical Trial

Official title:

A Single-dose, Open-label, Randomized, Crossover Study in Healthy Adult Subjects to Assess the Relative Bioavailability of a Zanubrutinib Tablet Compared to Zanubrutinib Capsules and to Evaluate the Effects of Food on the Pharmacokinetics of the Zanubrutinib Tablet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05547399
• Other study ID #: BGB-3111-115
• Status: Completed
• Phase: Phase 1
• Start date: June 7, 2022
• Est. completion date: December 7, 2022

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 7, 2022
• Est. primary completion date: December 7, 2022
• 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 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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Zanubrutinib
Administered orally 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	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
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 7
Primary	Maximum observed plasma concentration (Cmax)		Predose and up to 48 hours postdose up to Day 7
Primary	Time of the maximum observed plasma concentration (Tmax)		Predose and up to 48 hours postdose up to Day 7
Primary	Apparent terminal elimination half-life (t1/2)		Predose and up to 48 hours postdose up to Day 7
Primary	Apparent volume of distribution (Vz/F)		Predose and up to 48 hours postdose up to Day 7
Primary	Rate of decrease of concentration in the terminal phase (?z)		Predose and up to 48 hours postdose up to Day 7
Primary	Apparent oral clearance (CL/F)		Predose and up to 48 hours postdose up to Day 7
Secondary	Number of participants with adverse events (AEs)		Up to approximately 6 months
Secondary	Number of participants with clinically significant laboratory values	Laboratory values are based on hematology, clinical chemistry, and urinalysis test results	Up to approximately 6 months
Secondary	Number of participants with clinically significant electrocardiogram (ECG) results		Up to approximately 6 months
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 approximately 6 months