An Open-label, Fixed-Sequence Study in Healthy Male Subjects to Assess the Drug Interaction Potential of Multiple Doses of Zanubrutinib With a Drug "Cocktail" Representative for CYP3A4, CYP2C9, CYP2C19, P-gP and BCRP Substrates

BeiGene1 site in 1 country18 target enrollmentJune 7, 2018

ConditionsHealthy Subjects

InterventionsBGB-3111 and Drug Cocktail

DrugsBGB-3111 and Drug Cocktail

Overview

Phase: Phase 1
Intervention: BGB-3111 and Drug Cocktail
Conditions: Healthy Subjects
Sponsor: BeiGene
Enrollment: 18
Locations: 1
Primary Endpoint: PK parameters of probe drugs (warfarin, midazolam, digoxin, rosuvastatin, and omeprazole) derived from the plasma concentration time profile before and after oral administration of zanubrutinib
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

June 7, 2018

End Date

July 2, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

BeiGene

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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/m
•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.

Arms & Interventions

Single Arm: BGB-3111 + Drug Cocktail

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

Intervention: BGB-3111 and Drug Cocktail

Outcomes

Primary Outcomes

PK parameters of probe drugs (warfarin, midazolam, digoxin, rosuvastatin, and omeprazole) derived from the plasma concentration time profile before and after oral administration of zanubrutinib

Time Frame: Days 1-20

Time of the maximum observed plasma concentration (Tmax)