No relevant pharmacokinetic drug-drug interaction between nintedanib and pirfenidone

Nintedaniband pirfenidoneare approved treatments for idiopathic pulmonary fibrosis(IPF). This open-label, two-group trial investigated the pharmacokinetic drug-drug interactionbetween these two drugs in patients with IPF. Subjects not treated with antifibrotics at screening (Group 1, n=20) received a single nintedanibdose (150 mg) followed by pirfenidone(titrated to 801 mg thrice-daily) for 3 weeks, with a further single nintedanibdose (150 mg) on the last day (day 23). Subjects treated with pirfenidoneat screening (Group 2, n=17) continued to receive pirfenidonealone (801 mg thrice-daily) for 7 days, then co-administered with nintedanib(150 mg twice-daily) for a further 7 days, before single doses of both treatments on day 16. In Group 1, adjusted geometric mean (gMean) ratios (with/without pirfenidone) were 88.6% and 80.6% for nintedanibarea under the plasma concentration–time curve (AUC) and maximum plasma concentration (C max ), respectively. In Group 2, gMean ratios (with/without nintedanib) were 97.2% and 99.5% for pirfenidoneAUC and C max , respectively. For all parameters, the 90% confidence intervals included 100%, suggesting similar exposure for administration alone and when co-administered. Both treatments were well tolerated. These data indicate there is no relevant pharmacokinetic drug-drug interactionbetween nintedaniband pirfenidonewhen co-administered in IPF patients.