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

BeiGene

Status and phase

Completed

Phase 1

Conditions

Healthy

Male

Treatments

Drug: Rifabutin

Drug: Zanubrutinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT04470908

BGB-3111-112

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.