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Completed

NCT Number: NCT04470908

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

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

Key Exclusion Criteria:

  • Participants with a clinically relevant history or presence of any clinically significant disease
  • 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)
  • History of drug or alcohol abuse within 1 year prior to check-in
  • Use or intended use of any nonprescription medications/products including vitamins, minerals, herbal/plant-derived preparations within 7 days prior to check-in
  • A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result and/or a positive human immunodeficiency virus (HIV) at screening
  • Use of tobacco- or nicotine-containing products within 3 months prior to check-in
  • 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.

Treatment and study plan

Zanubrutinib

Drug

Single oral dose of 320 mg

Other names: BGB-3111, Brukinsa

rifabutin

Drug

Oral dose of 300 mg once daily

Primary outcomes

  1. Area Under the Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Zanubrutinib

    Time frame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11

  2. AUC From Time Zero to Infinity (AUC0-∞) of Zanubrutinib

    Time frame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11

  3. Maximum Observed Plasma Concentration (Cmax) of Zanubrutinib

    Time frame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11

  4. Time to the Maximum Observed Plasma Concentration (Tmax) of Zanubrutinib

    Time frame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11

  5. Time of the Last Quantifiable Concentration (Tlast) of Zanubrutinib

    Time frame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11

  6. Apparent Terminal Elimination Half-life (t1/2) of Zanubrutinib

    Time frame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11

  7. Apparent Oral Clearance (CL/F) of Zanubrutinib

    Time frame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11

  8. Apparent Volume of Distribution (Vz/F) of Zanubrutinib

    Time frame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11

Secondary outcomes

  1. Number of Participants Experiencing Adverse Events (AEs)

    Time frame: From the date of first study drug administration to 30 days after last dose (up to 3.5 months)

    Adverse events (AEs) and serious adverse events included for summary, AEs that start during or after the first dose, or start prior to the first dose and increases in severity after the first dose, including vital signs, physical examination, electrocardiogram, and laboratory parameters

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 14, 2020
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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