Clinical trial NCT04470908
Conditions: Healthy Male
Keywords: Phase 1 Healthy volunteers Pharmacokinetics
Sponsor: BeiGene
Start date: 2020-07-29; Completion date: 2020-11-10
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study was to determine the effect of the moderate cytochrome P450 3A (CYP3A) inducer rifabutin on the pharmacokinetics (PK) of zanubrutinib in healthy males.

Detailed description:

Arms: arm 1: Day 1: zanubrutinib

Days 3 to 10: rifabutin

Day 11: zanubrutinib and rifabutin
Interventions: intervention 1: Zanubrutinib intervention 2: Rifabutin
Intervention descriptions: intervention 1: Single oral dose of 320 mg intervention 2: Oral dose of 300 mg once daily

Protocol documents:
Prot_000.pdf: 
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I have read the protocol “A Phase 1, Open-label, Fixed-sequence Study to Investigate the 
Effect of the Moderate CYP3A Inducer Rifabutin on the Pharmacokinetics of Zanubrutinib in 
Healthy Male Subjects” and approve it: 
 
 
 
 
 
 
Date 
BeiGene, Ltd. 
 
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SAP_001.pdf: 
TITLE PAGE 
Statistical Analysis Plan 
A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effect of 
the Moderate CYP3A Inducer Rifabutin on the Pharmacokinetics of 
Zanubrutinib in Healthy Male Subjects 
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1. INTRODUCTION 
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2. STUDY OBJECTIVES  
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3. STUDY ENDPOINTS  
3.1. Primary Endpoints 
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4. STUDY DESIGN  
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5. SAMPLE SIZE JUSTIFICATION  
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6. STUDY TREATMENTS  
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Table 1: 
Presentation of Study Treatment Sequence for AE summaries 
Study Treatment Sequence 
Includes AEs with Onset on Study Day: 
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Table 2: 
Presentation of Study Treatments in TFLs  
Study Treatment 
Order in TFLs 
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7. DEFINITIONS OF POPULATIONS  
7.1. All Subjects Population  
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7.2. Safety Population  
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8. STATISTICAL METHODOLOGY  
8.1. General  
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and Half-life 
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Concentrations for Pharmacokinetic Analysis 
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Mixed Model Analysis 
proc mixed data = <data in>; 
  by parcat1n parcat1 pkday paramn param; 
  class trtan aperiod trtseqp usubjid; 
  model lpk = trtan aperiod trtseqp / cl residual ddfm = kr2; 
  lsmeans trtan / cl pdiff = control('1') alpha = 0.1; 
  random intercept / subject = usubjid(trtseqp);  
  ods output lsmeans = <data out>;   
  ods output diffs = <data out>; 
  ods output covparms = <data out>; 
run; 
8.6. Safety and Tolerability Assessments  
8.6.1. Adverse Events  
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8.6.2. Clinical Laboratory Parameters  
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8.6.6. Safety and Tolerability Statistical Methodology  
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11. REFERENCES  
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12. APPENDICES 
Appendix 1: 
Document History 
Status, Version 
Date of 
Change 
Summary/Reason for Changes 
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Quality Tolerance Limit Definitions 
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Page 20 of 20
Final