AUC = area under the plasma concentration versus time curve, from time zero to the last measurable concentration at t = 6 hr; Cmax = maximum measured plasma concentration over the time span specified; Tmax = time of maximum measured plasma concentration; t1/2 = time required for the concentration of the drug to halve * for n=4 patients only
Table 3: Treatment emergent adverse events affecting one or more participants (n=25) during the MAD Stage II of the pilot trial.