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OpenTrials
Completed

NCT Number: NCT05767398

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

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

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zanubrutinib

Drug

Administered as a tablet or capsule

Other names: BGB-3111, Brukinsa

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Predose and up to 48 hours postdose up to Day 10

  2. Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t)

    Time frame: Predose and up to 48 hours postdose up to Day 10

  3. Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)

    Time frame: Predose and up to 48 hours postdose up to Day 10

  4. Time of the maximum observed plasma concentration (Tmax)

    Time frame: Predose and up to 48 hours postdose up to Day 10

  5. Apparent terminal elimination half-life (t1/2)

    Time frame: Predose and up to 48 hours postdose up to Day 10

  6. Apparent volume of distribution (Vz/F)

    Time frame: Predose and up to 48 hours postdose up to Day 10

  7. Rate of decrease of concentration in the terminal phase (λz)

    Time frame: Predose and up to 48 hours postdose up to Day 10

  8. Apparent oral clearance (CL/F)

    Time frame: Predose and up to 48 hours postdose up to Day 10

Secondary outcomes

  1. Number of participants with adverse events (AEs)

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

  2. Number of participants with clinically significant laboratory values

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

    Laboratory values are based on hematology, clinical chemistry, and urinalysis test results

  3. Number of participants with clinically significant electrocardiogram (ECG) results

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

  4. Number of participants with clinically significant vital sign measurements

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

    Vital sign measurements include supine blood pressure, supine pulse rate, respiratory rate, and oral body temperature

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 14, 2023
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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