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

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ClinicalTrials.gov Identifier: NCT03561298
Recruitment Status : Completed
First Posted : June 19, 2018
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
BeiGene

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

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: BGB-3111 and Drug Cocktail Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : June 7, 2018
Actual Primary Completion Date : June 7, 2018
Actual Study Completion Date : July 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: Single Arm: BGB-3111 + Drug Cocktail
BGB-3111 and Drug Cocktail (midazolam, warfarin, omeprazole, digoxin and rosuvastatin)
Drug: BGB-3111 and Drug Cocktail
BGB-3111 and Drug Cocktail (midazolam, warfarin, omeprazole, digoxin and rosuvastatin)




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561298


Locations
United States, Florida
Covance Clinical Research Unit
Daytona Beach, Florida, United States, 32117
Sponsors and Collaborators
BeiGene

Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03561298     History of Changes
Other Study ID Numbers: BGB-3111-108
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by BeiGene:
Pharmacokinetics
Healthy subjects