A Pharmacokinetic Study to Assess Drug-drug Interaction Between Zanubrutinib and a Cocktail of Substrates in Healthy Subjects

BeiGene

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: BGB-3111 and Drug Cocktail

Study type: Interventional

Funder types: Industry

Identifiers

NCT03561298

BGB-3111-108

Details and patient eligibility

About

This study is designed to evaluate the safety and pharmacokinetic interaction of effects of multiple doses of zanubrutinib with a "Cocktail" of five probe drugs for cytochrome P450 (CYP) 3A, CYP2C9, CYP2C19, P-glycoprotein and breast cancer resistance protein (BCRP) in healthy subjects

Enrollment: 18 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: All Groups

• Male subjects in good health as determined by past medical history, physical examination, vital signs, ECG and laboratory tests at screening.
• Subjects must have a body mass index (BMI) between 18 and 32 kg/m2.
• Male subjects must agree to a highly effective method of birth control from screening until at least 90 days after the last dose of study drug.

Exclusion Criteria:

• Subjects 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 2 years prior to Check-In.
• Alcohol consumption of >21 units per week.
• A positive urine drug screen and/or positive alcohol breath test at Screening and/or 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.
• History of blood donation of 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Single Arm: BGB-3111 + Drug Cocktail

Experimental group

Description:

BGB-3111 and Drug Cocktail (midazolam, warfarin, omeprazole, digoxin and rosuvastatin)

Treatment:

Drug: BGB-3111 and Drug Cocktail