Healthy Subjects
Conditions
Keywords
Pharmacokinetics, Healthy subjects
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
Interventions
DRUGBGB-3111 and Drug Cocktail
BGB-3111 and Drug Cocktail (midazolam, warfarin, omeprazole, digoxin and rosuvastatin)
Sponsors
BeiGene
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Days 1-20 | AUC from time 0 to the last quantifiable concentration (AUC0-t) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability. | 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. |
Countries
United States
Outcome results
None listed