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

NCT05547399 | Completed Phase 1 FDA Drug

• 1 other identifier: BGB-3111-115
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• Maximum observed plasma concentration (Cmax)

  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

• Apparent terminal elimination half-life (t1/2)

  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

• Rate of decrease of concentration in the terminal phase (λz)

  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

Secondary Outcomes (4)

• Number of participants with adverse events (AEs)

  Up to approximately 6 months

• Number of participants with clinically significant laboratory values

  Up to approximately 6 months

• Number of participants with clinically significant electrocardiogram (ECG) results

  Up to approximately 6 months

• Number of participants with clinically significant vital sign measurements

  Up to approximately 6 months

Study Arms (2)

Low Dose Cohort

EXPERIMENTAL

Zanubrutinib will be administered as a single low dose of treatment (tablet) or reference (capsule) on separate occasions across several treatment sequences

Drug: Zanubrutinib

High Dose Cohort

EXPERIMENTAL

Zanubrutinib will be administered as a single high dose of treatment (tablet) or reference (capsule) on separate occasions across several treatment sequences

Drug: Zanubrutinib

Interventions

Zanubrutinib DRUG

Administered orally as a tablet or capsule

Also known as: BGB-3111, Brukinsa

High Dose Cohort; Low Dose Cohort

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

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) 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

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: September 16, 2022
• First Posted: September 21, 2022
• Study Start: June 7, 2022
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)