The purpose of this study is to investigate the effect of coadministration of phenytoin or itraconazole on the pharmacokinetics of BGB-16673 in healthy participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Fortrea Clinical Research Unit Inc
Madison, Wisconsin, United States
Part A and Part B: Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) of BGB-16673
Time frame: Part A: Day 1 and Day 20; Part B: Day 1 and Day 17
Part A and Part B: Area Under the Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast) of BGB-16673
Time frame: Part A: Day 1 and Day 20; Part B: Day 1 and Day 17
Part A and Part B: Maximum Observed Concentration (Cmax) of BGB-16673
Time frame: Part A: Day 1 and Day 20; Part B: Day 1 and Day 17
Part A and Part B: Time of the Maximum Observed Concentration (Tmax) of BGB-16673
Time frame: Part A: Day 1 and Day 20; Part B: Day 1 and Day 17
Part A and Part B: Apparent Terminal Elimination Half-life (t1/2) of BGB-16673
Time frame: Part A: Day 1 and Day 20; Part B: Day 1 and Day 17
Part A and Part B: Apparent Total Clearance (CL/F) of BGB-16673
Time frame: Part A: Day 1 and Day 20; Part B: Day 1 and Day 17
Part A and Part B: Apparent Volume of Distribution During the Terminal Phase (Vz/F) of BGB-16673
Time frame: Part A: Day 1 and Day 20; Part B: Day 1 and Day 17
Part A and Part B: Number of Participants with Adverse Events (AEs)
Safety will be assessed by monitoring and recording of all treatment emergent adverse events (AEs) graded by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
Time frame: Up to approximately 36 days
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Part A and Part B: Number of Participants with Clinically Significant Laboratory Values
Time frame: Up to approximately 36 days
Part A and Part B: Number of Participants with Clinically Significant Electrocardiogram (ECG) results
Time frame: Up to approximately 36 days
Part A and Part B: Number of Participants with Clinically Significant Vital Sign Measurements
Time frame: Up to approximately 36 days