Skip to main content
OpenTrials
Completed

NCT Number: NCT03561298

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BGB-3111 and Drug Cocktail

Drug

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

Primary outcomes

  1. 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

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

  2. 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

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

  3. 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

    Maximum observed plasma concentration (Cmax)

  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

    Time frame: Days 1-20

    Time of the maximum observed plasma concentration (Tmax)

Secondary outcomes

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

    Time frame: up to 26 days

    An adverse event is an unfavorable and unintended sign (including an abnormal laboratory finding, an abnormal electrocardiogram), symptom or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered related to study drug or not.

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 19, 2018
Registry last updated
Nov 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.