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

NCT05767398 | Completed Phase 1 FDA Drug

• 1 other identifier: BGB-3111-114
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (4)

• 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

  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

  Up to 30 days after last dose; up to approximately 7 weeks

Study Arms (2)

Sequence 1

EXPERIMENTAL

Zanubrutinib will be administered as a single dose of treatment (tablet) or reference (capsule) on separate occasions.

Drug: Zanubrutinib

Sequence 2

EXPERIMENTAL

Zanubrutinib will be administered as a single dose of treatment (tablet) or reference (capsule) on separate occasions.

Drug: Zanubrutinib

Interventions

Zanubrutinib DRUG

Administered as a tablet or capsule

Also known as: BGB-3111, Brukinsa

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• BeiGene: lead

Study Sites (1)

Fortrea Clinical Research Unit

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

zanubrutinib

Study Officials

• Study Director

  BeiGene

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 14, 2023
• Study Start: March 7, 2023
• Primary Completion: April 28, 2023
• Study Completion: April 28, 2023
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)