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

Sponsor
BeiGene (Industry)
Overall Status
Completed
CT.gov ID
NCT04470908
Collaborator
(none)
13
Enrollment
1
Location
1
Arm
2.6
Actual Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Aug 24, 2020
Actual Primary Completion Date :
Nov 11, 2020
Actual Study Completion Date :
Nov 11, 2020

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Area Under the Curve (AUC) from time zero to the time of the last quantifiable concentration (AUC0-t) of zanubrutinib [Days 1 and 11]

    2. AUC from time zero to infinity (AUC0-∞) of zanubrutinib [Days 1 and 11]

    3. Maximum observed plasma concentration (Cmax) of zanubrutinib [Days 1 and 11]

    4. Time to the maximum observed plasma concentration (Tmax) of zanubrutinib [Days 1 and 11]

    5. Apparent terminal elimination half-life (t1/2) of zanubrutinib [Days 1 and 11]

    6. Apparent oral clearance (CL/F) of zanubrutinib [Days 1 and 11]

    7. Apparent volume of distribution (Vz/F) of zanubrutinib [Days 1 and 11]

    Secondary Outcome Measures

    1. Number of participants experiencing Adverse Events (AEs) [Up to 19 days]

    2. Number of participants experiencing Serious Adverse Events (SAEs) [Up to 19 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Covance Clinical Research Unit Daytona Beach Florida United States 32117

    Sponsors and Collaborators

    • BeiGene

    Investigators

    • Study Director: William Novotny, MD, BeiGene

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BeiGene
    ClinicalTrials.gov Identifier:
    NCT04470908
    Other Study ID Numbers:
    • BGB-3111-112
    First Posted:
    Jul 14, 2020
    Last Update Posted:
    Sep 1, 2021
    Last Verified:
    Aug 1, 2021
    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
    Keywords provided by BeiGene
    Phase 1
    Healthy volunteers
    Pharmokinetics
    Additional relevant MeSH terms:
    Rifabutin
    Zanubrutinib

    Study Results

    No Results Posted as of Sep 1, 2021