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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-29

Study Completion Date

2020-11-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Male

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zanubrutinib + Rifabutin

Day 1: zanubrutinib

Days 3 to 10: rifabutin

Day 11: zanubrutinib and rifabutin

Group Type EXPERIMENTAL

Zanubrutinib

Intervention Type DRUG

Single oral dose of 320 mg

Rifabutin

Intervention Type DRUG

Oral dose of 300 mg once daily

Interventions

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Zanubrutinib

Single oral dose of 320 mg

Intervention Type DRUG

Rifabutin

Oral dose of 300 mg once daily

Intervention Type DRUG

Other Intervention Names

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BGB-3111 Brukinsa

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes