The Effect of Moderate CYP3A Inducer Rifabutin on the Pharmacokinetics of Zanubrutinib in Healthy Males
- Registration Number
- NCT04470908
- Lead Sponsor
- BeiGene
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 13
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Zanubrutinib + Rifabutin Rifabutin Day 1: zanubrutinib Days 3 to 10: rifabutin Day 11: zanubrutinib and rifabutin Zanubrutinib + Rifabutin Zanubrutinib Day 1: zanubrutinib Days 3 to 10: rifabutin Day 11: zanubrutinib and rifabutin
- Primary Outcome Measures
Name Time Method Time to the Maximum Observed Plasma Concentration (Tmax) of Zanubrutinib Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11 Area Under the Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Zanubrutinib Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11 AUC From Time Zero to Infinity (AUC0-∞) of Zanubrutinib Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11 Maximum Observed Plasma Concentration (Cmax) of Zanubrutinib Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11 Apparent Terminal Elimination Half-life (t1/2) of Zanubrutinib Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11 Apparent Oral Clearance (CL/F) of Zanubrutinib Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11 Apparent Volume of Distribution (Vz/F) of Zanubrutinib Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11 Time of the Last Quantifiable Concentration (Tlast) of Zanubrutinib Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11
- Secondary Outcome Measures
Name Time Method Number of Participants Experiencing Adverse Events (AEs) 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
Trial Locations
- Locations (1)
Covance Clinical Research Unit
🇺🇸Daytona Beach, Florida, United States