Bioequivalence of a Zanubrutinib Tablet Compared to Capsules in Healthy Adult Participants
Completed · Phase 1
Conditions studied: Healthy Volunteers
In brief
Study to determine the bioequivalence of a zanubrutinib tablet compared to capsules in healthy adult participants.
Key facts
- Study ID
- NCT05767398
- Run by
- BeiGene
- People needed
- 58
- Starts
- 2023-03-07
- Expected to finish
- 2023-04-28
- Last updated by the study team
- 2024-10-26
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
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
- Note: Other protocol defined Inclusion/Exclusion criteria apply
Where it is running
- Fortrea Clinical Research Unit — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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