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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04470908
• Other study ID #: BGB-3111-112
• Status: Completed
• Phase: Phase 1
• Start date: July 29, 2020
• Est. completion date: November 10, 2020

Study information

• Verified date: March 2023
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 10, 2020
• Est. primary completion date: November 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Male

Intervention

Drug:
• Zanubrutinib
Single oral dose of 320 mg
• Rifabutin
Oral dose of 300 mg once daily

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	AUC From Time Zero to Infinity (AUC0-8) 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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	Number of Participants Experiencing Adverse Events (AEs)	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	From the date of first study drug administration to 30 days after last dose (up to 3.5 months)