Odalasvir + Sovaprevir = Unknown or no reaction

Study Design

This was an open-label, randomized study to evaluate coadministration of sovaprevir (formerly ACH-1625), and odalasvir (formerly ACH-3102) in parallel groups of healthy subjects under fed and fasting conditions. Four groups of 6 subjects were enrolled and given single 300mg single dose of sovaprevir on Day1 of the study; groups 1 and 2 were dosed after a standard meal while groups 3 and 4 were dosed in a fasted state.On day 5, after a 2-day washout period, groups 1 and 3 were administered sovaprevir 300mg + odalasvir 300mg, while groups 2 and 4 were given sovaprevir 300mg + placebo .

Study Results

In the fed state, concomitant administration of odalasvir and sovaprevir resulted in 5% increase in AUC and 4% decrease in Cmax for sovaprevir. The Cmax and AUC for odalasvir were slightly higher in patients who received sovaprevir + odalasvir compared with those who received odalasvir alone; no specific values were indicated.In the fasted state, when coadministered with odalasvir, the AUC and Cmax for sovaprevir were decreased by 23% and 11%, respectively. The Cmax and AUC for odalasvir were slightly lower in patients who received sovaprevir + odalasvir compared with those who received odalasvir alone; no specific values were indicated.

Study Conclusions

References

J Hui, L Robarge, H Robison, et al. No clinically significant pharmacokinetic interaction between sovaprevir and ach-3102 in healthy volunteers [abstract]. 48th Annual Meeting Of The European Association For The Study Of The Liver (easl). Amsterdam. ; 2013.