Relative Bioavailability of Zanubrutinib Tablets Compared to Capsules and Effects of Food on the Pharmacokinetics of the Tablet in Healthy Adults
Completed · Phase 1
Conditions studied: Healthy Volunteers
In brief
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.
Key facts
- Study ID
- NCT05547399
- Run by
- BeiGene
- People needed
- 43
- Starts
- 2022-06-07
- Expected to finish
- 2022-12-07
- 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 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
- Note: Other protocol defined Inclusion/Exclusion criteria may apply
Where it is running
- Fortrea Clinical Research Unit — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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