Relative Bioavailability of Zanubrutinib Tablets Compared to Capsules and Effects of Food on the Pharmacokinetics of the Tablet in Healthy Adults

• Sponsor: BeiGene (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05547399
• Collaborator: (none)
• Enrollment: 48
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 5.8
• Patients Per Site: 24
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief Summary

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.

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Single-dose, Open-label, Randomized, Crossover Study in Healthy Adult Subjects to Assess the Relative Bioavailability of a Zanubrutinib Tablet Compared to Zanubrutinib Capsules and to Evaluate the Effects of Food on the Pharmacokinetics of the Zanubrutinib Tablet
• Actual Study Start Date: Jun 7, 2022
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low Dose Cohort Zanubrutinib will be administered as a single low dose of treatment (tablet) or reference (capsule) on separate occasions across several treatment sequences	Drug: Zanubrutinib; Administered orally as a tablet or capsule; Other Names: BGB-3111 Brukinsa
Experimental: High Dose Cohort Zanubrutinib will be administered as a single high dose of treatment (tablet) or reference (capsule) on separate occasions across several treatment sequences	Drug: Zanubrutinib; Administered orally as a tablet or capsule; Other Names: BGB-3111 Brukinsa

Outcome Measures

Primary Outcome Measures

1. 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 7]

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 7]

3. Maximum observed plasma concentration (Cmax) [Predose and up to 48 hours postdose up to Day 7]

4. Time of the maximum observed plasma concentration (Tmax) [Predose and up to 48 hours postdose up to Day 7]

5. Apparent terminal elimination half-life (t1/2) [Predose and up to 48 hours postdose up to Day 7]

6. Apparent volume of distribution (Vz/F) [Predose and up to 48 hours postdose up to Day 7]

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

8. Apparent oral clearance (CL/F) [Predose and up to 48 hours postdose up to Day 7]

Secondary Outcome Measures

1. Number of participants with adverse events (AEs) [Up to approximately 6 months]

2. Number of participants with clinically significant laboratory values [Up to approximately 6 months]

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

3. Number of participants with clinically significant electrocardiogram (ECG) results [Up to approximately 6 months]

4. Number of participants with clinically significant vital sign measurements [Up to approximately 6 months]

   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 signs measurements, and clinical laboratory evaluations as assessed by the investigator or designee

• Female participants of non-childbearing potential only

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) 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

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: NCT05547399
• Other Study ID Numbers: BGB-3111-115
• First Posted: Sep 21, 2022
• Last Update Posted: Sep 21, 2022
• Last Verified: Sep 1, 2022

• 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 Sep 21, 2022