This study is designed to evaluate the influence of ethnic factors on the safety, tolerability, and pharmacokinetics (PK) of BGB-23339 after multiple dosing under fasting condition in healthy Japanese and Caucasian participants.
The study comprises 2 parts: Part A is a randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability, and PK profile of BGB-23339 in healthy Japanese subjects. Part B is a randomized, double-blind, placebo-controlled, multiple-dose study to evaluate the safety, tolerability, and PK profile of BGB-23339 in healthy Caucasian subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
PPD
Las Vegas, Nevada, United States
Number of participants with Adverse Events (AEs)
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory values, vital signs, and electrocardiogram results.
Time frame: Duration of Study (Up to 11 weeks)
Area under the plasma concentration-time curve (AUC) of BGB-23339 from time zero to last quantifiable time (AUClast) quantifiable time (AUClast)
Time frame: Up to Day 10
Area under the plasma concentration-time curve (AUC) of BGB-23339 from time zero to end of dosing interval (AUCtau)
Time frame: Up to Day 10
Maximum observed plasma concentration (Cmax) of BGB-23339
Time frame: Up to Day 10
Time to maximum plasma concentration (Tmax) of BGB-23339
Time frame: Up to Day 10
Trough plasma concentration (Ctrough) of BGB-23339
Time frame: Up to Day 10
Apparent terminal elimination half-life (t½) of BGB-23339
Time frame: Up to Day 10
Apparent systemic clearance (CL/F) of BGB-23339
Time frame: Up to Day 10
Apparent volume of distribution (Vz/F) of BGB-23339
Time frame: Up to Day 10
Metabolite to parent ratio for BGB-23339 and its metabolite BGB-25808
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Time frame: Up to Day 10