Positive Outcome Of Drug-Drug Interaction Trial With Intravenous Iclaprim
Drug-Drug Interaction Trial
Arpida announced results of a Phase I trial investigating the possible interaction between intravenous iclaprim and warfarin.
Warfarin is widely used for the prophylaxis of thrombosis and embolism and its dosing needs to be well-controlled. The drug-drug interaction study comprised 24 healthy volunteers and was performed in Germany. Dosing of warfarin with and without pre- and co-administration of iclaprim (1.6 mg/kg infused over 60 minutes) was investigated.
Administration of intravenous iclaprim at this supra-therapeutic dose was assessed to be safe for clinical applications. It had no significant effect on the pharmakonetics and pharmacodynamics of warfarin. Moreover, the trial results again confirm the good safety and tolerability profile of iclaprim.
Dr Paul Hadvary, Head of Development of Arpida Ltd., commented: "The results of this Phase I study are very positive, showing that iclaprim has no significant effect on the pharmacokinetics of warfarin, which is widely used in the targeted patient population. The results expand the experience gathered in an earlier Phase I study in which the interaction between ketaconazole and iclaprim was investigated. In summary, iclaprim's drug-drug interaction profile looks favourable. This is of great importance as iclaprim is expected to be administered to patients with significant co-morbidities and receiving several other medications. These Phase I data add substantial weight to the NDA package that we intend to file shortly with the U.S. Food and Drug Administration for intravenous iclaprim in its first indication: complicated Skin and Skins Structure Infections (cSSSI)."