The purpose of this study is to evaluate the potential for a PK drug-drug interaction when IDX719, simeprevir, TMC647055 and low-dose ritonavir (RTV) are administered in combination. Safety and tolerability will also be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
IDX719 will be supplied as a 50 mg tablet for oral administration.
Simeprevir will be supplied as 75 mg capsules for oral administration.
TMC647055 will be supplied as 150 mg capsules for oral administration.
Observed maximum plasma drug concentration (Cmax)
Time frame: Up to 14 days
Time to maximum concentration (Tmax)
Time frame: Up to 14 days
Area under the drug concentration-plasma time curve from time zero to last measurable concentration (AUC0-t)
Time frame: Up to 14 days
Predose trough concentration (Ctrough)
Time frame: Up to 14 days
Apparent terminal elimination rate constant
Time frame: Up to 14 days
Observed terminal half-life (T1/2)
Time frame: Up to 14 days
Percentage of participants experiencing serious adverse events (SAEs)
Time frame: Up to 28 days
Percentage of participants experiencing adverse events (AEs)
Time frame: Up to 28 days
Percentage of participants with Grade 1-4 laboratory abnormalities
Time frame: Up to 28 days
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RTV will be supplied as 80 mg/mL solution for oral administration.