Phase 1 study in healthy subjects to determine the effect of rifampin (Part A) or itraconazole (Part B) on the pharmacokinetics of BGB-3111
This is a Phase 1 open-label, parallel-group study in healthy subjects. Subjects in Part A will receive a single dose of BGB-3111 before and during consecutive daily doses of strong cytochrome P450 CYP3A inducer, rifampin, to investigate its effect on the pharmacokinetics of BGB-3111. Following an interim data analysis, subjects in Part B will receive a single dose of BGB-3111 before and during consecutive daily doses of strong CYP3A inhibitor, itraconazole, to investigate its effect on the pharmacokinetics of BGB-3111.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
40
320 mg BGB-3111 single oral dose
600 mg rifampin once daily
Up to 80 mg BGB-3111 single oral dose
West Coast Clinical Trials (WCCT)
Cypress, California, United States
Plasma concentration of BGB-3111 and rifampin to evaluate protocol specified PK parameters
Time frame: Part A: Days 1 and 10
Plasma concentration of BGB-3111 and itraconazole to evaluate protocol specified PK parameters
Time frame: Part B: Days 1 and 6
Safety as assessed by adverse events
Time frame: Part A: up to 19 days: Part B: up to 14 days
Safety as assessed by electrocardiogram (ECG) measurements
Time frame: Part A: Days 1 and 10, from screening to end of study visit; up to Day 19; Part B: Days 1 and 6, from screening to end of study visit; up to Day 14
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
200 mg itraconazole once daily