Summary

A pharmacokinetic/pharmacodynamic (PK/PD) modeling study on the effect of the BK channel blocker GAL021 found that it produced rapid reversal of opioid-induced respiratory depression (OIRD) in a population of healthy male volunteers. This article discusses a study assessing whether GAL21 stimulates breathing in OIRD and evaluated its safety in a proof-of-concept, double-blind crossover study on isohypercapnic ventilation and a subsequent double-blind exploratory study on poikilocapnic ventilation and nonrespiratory end points.