This study will evaluate the safety, tolerability, and pharmacokinetics of BGB-23339 and food effects in healthy participants
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
92
Q PHARM
Herston, Queensland, Australia
Nucleus Network
Melbourne, Victoria, Australia
The Affiliated Hospital of Qingdao University Branch West Coast
Qingdao, Shandong, China
Number of Participants Experiencing Adverse Events (AEs)
Time frame: Up to approximately 7 weeks
Number of participants with clinically significant changes from baseline in vital signs
Vital signs include blood pressure and pulse rate
Time frame: Up to approximately 4 weeks
Number of participants with clinically significant changes from baseline in clinical laboratory values
Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis
Time frame: Up to approximately 4 weeks
Area under the plasma concentration-time curve from time zero to last quantifiable time (AUClast) for Parts A, B, C and D
Time frame: Up to approximately 4 weeks
Area under the plasma concentration-time curve from time zero to 24 hours postdose (AUC0-24) for Part D only
Time frame: Up to approximately 4 weeks
Area under the plasma concentration-time curve from time zero to end of dosing interval (AUCtau) for Parts A, B, C and D
Time frame: Up to approximately 4 weeks
Area under the plasma concentration-time curve from time zero to infinity (AUCinf) for Parts A, B, C, and D
Time frame: Up to approximately 4 weeks
Maximum observed plasma concentration (Cmax) for Parts A, B, C and D
Time frame: Up to approximately 4 weeks
Time to maximum plasma concentration (Tmax) for Parts A, B, C and D
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Time frame: Up to approximately 4 weeks
Trough plasma concentration (Ctrough) for Parts A, B, and C
Time frame: Up to approximately 4 weeks
Apparent terminal elimination half-life (t½) for Parts A, B, C and D
in fed and fasted states for BGB-23339
Time frame: Up to approximately 4 weeks
Apparent systemic clearance (CL/F) for Parts A, B, and C
Time frame: Up to approximately 4 weeks
Apparent volume of distribution (Vz/F) for Parts A, B, and C
Time frame: Up to approximately 4 weeks
Accumulation ratios, and metabolite to parent ratio for BGB-23339 and its metabolite BGB-25808 as appropriate for Parts A, B, C and D
Time frame: Up to approximately 4 weeks