The purpose of this study is to provide dosing recommendations for the coadministration of BMS-663068 and Rifabutin with and without Ritonavir in upcoming Phase 3 studies and for prescribing information purposes
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
102
GSK Investigational Site
Austin, Texas, United States
Maximum observed plasma concentration (Cmax) of BMS-626529
Time frame: Day 2 to Day 15
Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-626529
Time frame: Day 2 to Day 15
Time of maximum observed plasma concentration (Tmax) of BMS-626529
Time frame: Day 2 to Day 15
Concentration at 12 hours after dosing (C12) of BMS-626529
Time frame: Day 2 to Day 15
Trough observed plasma concentration (Ctrough) of BMS-626529 (predose)
Time frame: Day 2 to Day 15
Safety and tolerability include incidence of adverse events (AEs), serious AEs (SAEs), AEs leading to discontinuation, deaths, marked laboratory abnormalities, and abnormalities in vital signs, physical examination, and 12-lead electrocardiograms (ECGs)
Time frame: Up to Day 30 after discontinuation of dose (approximately 45 days)
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