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OpenTrials
Completed

NCT Number: NCT05547399

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

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.

Completed

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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 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

Treatment and study plan

Zanubrutinib

Drug

Administered orally as a tablet or capsule

Other names: BGB-3111, Brukinsa

Primary outcomes

  1. 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 7

  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 7

  3. Maximum observed plasma concentration (Cmax)

    Time frame: Predose and up to 48 hours postdose up to Day 7

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

    Time frame: Predose and up to 48 hours postdose up to Day 7

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

    Time frame: Predose and up to 48 hours postdose up to Day 7

  6. Apparent volume of distribution (Vz/F)

    Time frame: Predose and up to 48 hours postdose up to Day 7

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

    Time frame: Predose and up to 48 hours postdose up to Day 7

  8. Apparent oral clearance (CL/F)

    Time frame: Predose and up to 48 hours postdose up to Day 7

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to approximately 6 months

  2. Number of participants with clinically significant laboratory values

    Time frame: Up to approximately 6 months

    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 approximately 6 months

  4. Number of participants with clinically significant vital sign measurements

    Time frame: Up to approximately 6 months

    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, 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 21, 2022
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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