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

BeiGene

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Zanubrutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05767398

BGB-3111-114

Details and patient eligibility

About

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

Enrollment: 58 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Sequence 1

Experimental group

Description:

Zanubrutinib will be administered as a single dose of treatment (tablet) or reference (capsule) on separate occasions.

Treatment:

Drug: Zanubrutinib

Sequence 2

Experimental group

Description:

Zanubrutinib will be administered as a single dose of treatment (tablet) or reference (capsule) on separate occasions.

Treatment:

Drug: Zanubrutinib