The purpose of this study is to compare the amount of Atazanavir (ATV) and Cobicistat (COBI) in the bodies of healthy adult participants when taken as a combination formulation, and when ATV is administered as an oral powder at the same time as COBI administered as an oral tablet. The ATV/COBI combination formulation and ATV powder will be taken with food.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
34
Specified Dose on Specified Days
Specified Dose on Specified Days
Specified Dose on Specified Days
PPD Development, LP
Austin, Texas, United States
Maximum observed plasma concentration (Cmax) of Atazanavir (ATV)
Time frame: Up to Day 10
Cmax of Cobicistat (COBI)
Time frame: Up to Day 10
Area under the plasma concentration- time Curve from time zero extrapolated to infinite time (AUC(INF)) of ATV
Time frame: Up to Day 10
AUC(INF) of COBI
Time frame: Up to Day 10
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 70 days
Incidence of AEs leading to discontinuation
Time frame: Up to 40 days
Incidence of deaths
Time frame: Up to 40 days
Marked abnormalities in clinical laboratory test results
Time frame: Up to 40 days
Incidence of marked abnormalities in vital sign measurements: Blood Pressure
Time frame: Up to 40 days
Incidence of marked abnormalities in vital sign measurements: Heart Rate
Time frame: Up to 40 days
Incidence of marked abnormalities in Electrocardiogram (ECG) recording
Time frame: Up to 40 days
Incidence of Palatability questionnaire results
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Time frame: Up to 40 days