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

NCT03561298 | Completed Phase 1 FDA Drug

• 1 other identifier: BGB-3111-108
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Subjects

Keywords

Pharmacokinetics; Healthy subjects

Outcome Measures

Primary Outcomes (4)

• 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

  AUC from time 0 to the last quantifiable concentration (AUC0-t)

  Days 1-20

• 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

  AUC from time 0 to infinity (AUC0 ∞; calculated as appropriate and allowed by the available data)

  Days 1-20

• 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

  Maximum observed plasma concentration (Cmax)

  Days 1-20

• 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 of the maximum observed plasma concentration (Tmax)

  Days 1-20

Secondary Outcomes (1)

• Number of participants with adverse events as a measure of safety and tolerability.

  up to 26 days

Study Arms (1)

Single Arm: BGB-3111 + Drug Cocktail

EXPERIMENTAL

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

Drug: BGB-3111 and Drug Cocktail

Interventions

BGB-3111 and Drug Cocktail DRUG

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

Single Arm: BGB-3111 + Drug Cocktail

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BeiGene: lead

Study Sites (1)

Covance Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Interventions

zanubrutinib

Study Officials

• William Novotny, MD

  BeiGene

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: June 19, 2018
• Study Start: June 7, 2018
• Primary Completion: June 7, 2018
• Study Completion: July 2, 2018
• Last Updated: November 4, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)