Covance Clinical Research Unit
Daytona Beach, Florida, 32117, United States
NCT Number: NCT03561298
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
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Notify Me18 year–60 year
Male
Interventional
Phase 1
Daytona Beach, Florida, 32117, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All Groups
Exclusion criteria
BGB-3111 and Drug Cocktail (midazolam, warfarin, omeprazole, digoxin and rosuvastatin)
Time frame: Days 1-20
AUC from time 0 to the last quantifiable concentration (AUC0-t)
Time frame: Days 1-20
AUC from time 0 to infinity (AUC0 ∞; calculated as appropriate and allowed by the available data)
Time frame: Days 1-20
Maximum observed plasma concentration (Cmax)
Time frame: Days 1-20
Time of the maximum observed plasma concentration (Tmax)
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.
BeiGene
Industry
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
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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.
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