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

• Status: Completed
• Trial end date: 2020-11-11
• Target enrollment: 0
• Participant gender: Male

Summary

The primary objective of this study is to determine the effect of the moderate cytochrome P450 3A (CYP3A) inducer rifabutin on the pharmacokinetics (PK) of zanubrutinib in healthy males.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: BeiGene
• Treatments: Rifabutin; Zanubrutinib

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/m2

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.