The completed study evaluated the safety and efficacy of oral RSD1235 as a function of fed and fasted states in normal and poor metabolizers.
On the basis of the results, Cardiome has now begun enrolling patients into a phase Ic study evaluating safety and tolerability after multi-day dosing.
The series of phase I studies has been undertaken in order to determine the dosing regimen to be used in a phase II efficacy study planned to begin in the second half of 2005. Oral RSD1235 will be studied in patients to confirm the ability of the novel agent to prevent or delay the reoccurrence of atrial fibrillation (AF).
Oral RSD1235 is designed to be used as a follow-on therapy to intravenous RSD1235, Cardiome’s lead anti-arrhythmic product currently in its second and third phase III trials for the conversion of AF.