HPC1006 Atorvastatin and simvastatin C112 Escitalopram C110 Methadone C120 Cyclosporine and tacrolimus HPC1001 TMC647055 C123 Efavirenz and raltegravir C105 Rifampin C108 Digoxin and rosuvastatin GS-5885 Population PK Simeprevir Population PK meta-analysis analyses Global PPK Study C205-C206 Bayesian estimation PPK C208 PPK Bayesian estimation C216 PPK Bayesian estimation HPC3007 Bayesian estimation PPK C212 PPK Bayesian estimation HPC3011 Bayesian estimation PPK C201-C205 Effect of bilirubin PPK C215 PPK Effect of bilirubin * Indicates the primary aim of the study. Bioequivalence of different formulations. § Subjects who † would be eligible to receive the drug if approved for the proposed indication. Evaluator’s summary and conclusions on pharmacokinetics Pharmacokinetics in healthy subjects Following single, PO, 200 mg doses of either the Phase IIa (F007) or IIb (F020) capsule formulations in healthy subjects the median Tmax of simeprevir was 6.0 h and the mean t½ values were 10.5 h to 10.94 h, respectively. The absolute bioavailability of simeprevir is not known at this time.
HPC1006 Atorvastatin and simvastatin C112 Escitalopram C110 Methadone C120 Cyclosporine and tacrolimus HPC1001 TMC647055 C123 Efavirenz and raltegravir C105 Rifampin C108 Digoxin and rosuvastatin GS-5885 Population PK analyses Simeprevir Global PPK Study Population PK meta-analysis C205-C206 PPK Bayesian estimation C208 PPK Bayesian estimation C216 PPK Bayesian estimation HPC3007 PPK Bayesian estimation C212 PPK Bayesian estimation HPC3011 PPK Bayesian estimation C201-C205 PPK Effect of bilirubin C215 PPK Effect of bilirubin * Indicates the primary aim of the study. † Bioequivalence of different formulations. § Subjects who would be eligible to receive the drug if approved for the proposed indication. Evaluator’s summary and conclusions on pharmacokinetics Pharmacokinetics in healthy subjects Following single, PO, 200 mg doses of either the Phase IIa (F007) or IIb (F020) capsule formulations in healthy subjects the median Tmax of simeprevir was 6.0 h and the mean t½ values were 10.5 h to 10.94 h, respectively. The absolute bioavailability of simeprevir is not known at this time.
auspar-simeprevir-141027.docx