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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-07

Study Completion Date

2023-04-28

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Sequence 1

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

Group Type EXPERIMENTAL

Zanubrutinib

Intervention Type DRUG

Administered as a tablet or capsule

Sequence 2

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

Group Type EXPERIMENTAL

Zanubrutinib

Intervention Type DRUG

Administered as a tablet or capsule

Interventions

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Zanubrutinib

Administered as a tablet or capsule

Intervention Type DRUG

Other Intervention Names

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BGB-3111 Brukinsa

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes