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The Effect of Moderate CYP3A Inducer Rifabutin on the Pharmacokinetics of Zanubrutinib in Healthy Males

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04470908
Recruitment Status : Completed
First Posted : July 14, 2020
Last Update Posted : September 1, 2021
Sponsor:
Information provided by (Responsible Party):
BeiGene

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

Condition or disease Intervention/treatment Phase
Healthy Male Drug: Zanubrutinib Drug: Rifabutin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 24, 2020
Actual Primary Completion Date : November 11, 2020
Actual Study Completion Date : November 11, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Zanubrutinib + Rifabutin

Day 1: zanubrutinib

Days 3 to 10: rifabutin

Day 11: zanubrutinib and rifabutin

Drug: Zanubrutinib
Single oral dose of 320 mg
Other Names:
  • BGB-3111
  • Brukinsa

Drug: Rifabutin
Oral dose of 300 mg once daily




Primary Outcome Measures :
  1. Area Under the Curve (AUC) from time zero to the time of the last quantifiable concentration (AUC0-t) of zanubrutinib [ Time Frame: Days 1 and 11 ]
  2. AUC from time zero to infinity (AUC0-∞) of zanubrutinib [ Time Frame: Days 1 and 11 ]
  3. Maximum observed plasma concentration (Cmax) of zanubrutinib [ Time Frame: Days 1 and 11 ]
  4. Time to the maximum observed plasma concentration (Tmax) of zanubrutinib [ Time Frame: Days 1 and 11 ]
  5. Apparent terminal elimination half-life (t1/2) of zanubrutinib [ Time Frame: Days 1 and 11 ]
  6. Apparent oral clearance (CL/F) of zanubrutinib [ Time Frame: Days 1 and 11 ]
  7. Apparent volume of distribution (Vz/F) of zanubrutinib [ Time Frame: Days 1 and 11 ]

Secondary Outcome Measures :
  1. Number of participants experiencing Adverse Events (AEs) [ Time Frame: Up to 19 days ]
  2. Number of participants experiencing Serious Adverse Events (SAEs) [ Time Frame: Up to 19 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  1. Males of any race, between 18 and 65 years of age, inclusive.
  2. Male participants in good health as determined by past medical history, physical examination, vital signs, ECG and laboratory tests at screening
  3. Must have a body mass index (BMI) between 18 and 32 kg/m2

Key Exclusion Criteria:

  1. Participants with a clinically relevant history or presence of any clinically significant disease
  2. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair will be allowed)
  3. History of drug or alcohol abuse within 1 year prior to check-in
  4. Use or intended use of any nonprescription medications/products including vitamins, minerals, herbal/plant-derived preparations within 7 days prior to check-in
  5. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result and/or a positive human immunodeficiency virus (HIV) at screening
  6. Use of tobacco- or nicotine-containing products within 3 months prior to check-in
  7. Use or intended use of any prescription medications/products within 14 days prior to check-in

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04470908


Locations
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United States, Florida
Covance Clinical Research Unit
Daytona Beach, Florida, United States, 32117
Sponsors and Collaborators
BeiGene
Investigators
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Study Director: William Novotny, MD BeiGene
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT04470908    
Other Study ID Numbers: BGB-3111-112
First Posted: July 14, 2020    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BeiGene:
Phase 1
Healthy volunteers
Pharmokinetics
Additional relevant MeSH terms:
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Rifabutin
Zanubrutinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antitubercular
Antitubercular Agents