Clinical trial NCT04470908: The Effect of Moderate CYP3A Inducer Rifabutin on the Pharmacokinetics of Zanubrutinib in Healthy Males
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Male
Keywords: Phase 1
Healthy volunteers
Pharmacokinetics
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2020-07-14
Enrollment: 13
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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/m\^2

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.

Primary outcomes:
measure: Area Under the Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Zanubrutinib
timeFrame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11
measure: AUC From Time Zero to Infinity (AUC0-∞) of Zanubrutinib
timeFrame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11
measure: Maximum Observed Plasma Concentration (Cmax) of Zanubrutinib
timeFrame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11
measure: Time to the Maximum Observed Plasma Concentration (Tmax) of Zanubrutinib
timeFrame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11
measure: Time of the Last Quantifiable Concentration (Tlast) of Zanubrutinib
timeFrame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11
measure: Apparent Terminal Elimination Half-life (t1/2) of Zanubrutinib
timeFrame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11
measure: Apparent Oral Clearance (CL/F) of Zanubrutinib
timeFrame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 36 hours postdose on Days 1 and 11
measure: Apparent Volume of Distribution (Vz/F) of Zanubrutinib
timeFrame: 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:
measure: Number of Participants Experiencing Adverse Events (AEs)
timeFrame: From the date of first study drug administration to 30 days after last dose (up to 3.5 months)
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Covance Clinical Research Unit
state: Florida
Study officials:
affiliation: BeiGene
name: Study Director
role: PRINCIPAL_INVESTIGATOR
References: