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

• Sponsor: BeiGene (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05767398
• Collaborator: (none)
• Enrollment: 58
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 3.8
• Patients Per Site: 29
• Patients Per Site Per Month: 7.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Zanubrutinib	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Single-dose, Open-label, Randomized, Replicate Crossover Study in Healthy Adult Subjects to Assess the Bioequivalence of a Zanubrutinib Tablet Compared to Zanubrutinib Capsules
• Actual Study Start Date: Mar 7, 2023
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequence 1 Zanubrutinib will be administered as a single dose of treatment (tablet) or reference (capsule) on separate occasions.	Drug: Zanubrutinib; Administered as a tablet or capsule; Other Names: BGB-3111 Brukinsa
Experimental: Sequence 2 Zanubrutinib will be administered as a single dose of treatment (tablet) or reference (capsule) on separate occasions.	Drug: Zanubrutinib; Administered as a tablet or capsule; Other Names: BGB-3111 Brukinsa

Outcome Measures

Primary Outcome Measures

1. Maximum observed plasma concentration (Cmax) [Predose and up to 48 hours postdose up to Day 10]

2. Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t) [Predose and up to 48 hours postdose up to Day 10]

3. Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) [Predose and up to 48 hours postdose up to Day 10]

4. Time of the maximum observed plasma concentration (Tmax) [Predose and up to 48 hours postdose up to Day 10]

5. Apparent terminal elimination half-life (t1/2) [Predose and up to 48 hours postdose up to Day 10]

6. Apparent volume of distribution (Vz/F) [Predose and up to 48 hours postdose up to Day 10]

7. Rate of decrease of concentration in the terminal phase (λz) [Predose and up to 48 hours postdose up to Day 10]

8. Apparent oral clearance (CL/F) [Predose and up to 48 hours postdose up to Day 10]

Secondary Outcome Measures

1. Number of participants with adverse events (AEs) [Up to 30 days after last dose; up to approximately 7 weeks]

2. Number of participants with clinically significant laboratory values [Up to 30 days after last dose; up to approximately 7 weeks]

   Laboratory values are based on hematology, clinical chemistry, and urinalysis test results

3. Number of participants with clinically significant electrocardiogram (ECG) results [Up to 30 days after last dose; up to approximately 7 weeks]

4. Number of participants with clinically significant vital sign measurements [Up to 30 days after last dose; up to approximately 7 weeks]

   Vital sign measurements include supine blood pressure, supine pulse rate, respiratory rate, and oral body temperature

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Labcorp Clinical Research Unit Inc.	Daytona Beach	Florida	United States	32117
2	Labcorp Clinical Research Unit Inc.	Dallas	Texas	United States	75247

Sponsors and Collaborators

• BeiGene

Investigators

• Study Director: Study Director, BeiGene

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: BeiGene
• ClinicalTrials.gov Identifier: NCT05767398
• Other Study ID Numbers: BGB-3111-114
• First Posted: Mar 14, 2023
• Last Update Posted: Mar 17, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Zanubrutinib

Study Results

No Results Posted as of Mar 17, 2023