The purpose of this 3-part study is to evaluate the potential impact of simeprevir and food on pharmacokinetics (PK) of IDX719 in healthy participants. Part 1 will evaluate potential PK interactions between IDX719 and simeprevir. Part 2 will evaluate the effect of food on the PK of IDX719 in combination with simeprevir. Part 3 will evaluate the impact of high- versus low-fat meals on the PK of IDX719.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
50 mg tablet for oral administration
150 mg capsule for oral administration
Area under the plasma concentration-time curve (AUC) at steady-state over dosing interval (AUCss)
Time frame: Up to 30 days
Maximum observed plasma concentration (Cmax)
Time frame: Up to 30 days
AUC from time zero to infinity
Time frame: Up to 30 days
Trough plasma concentration (Ctrough)
Time frame: Up to 30 days
Percentage of participants experiencing serious adverse events (SAEs)
Time frame: Up to 30 days
Percentage of participants experiencing adverse events (AEs)
Time frame: Up to 30 days
Percentage of participants experiencing Grade 1-4 laboratory abnormalities
Time frame: Up to 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.