Additional Relevant Details Marinus  has dosed the first subject in its Phase 1 clinical trial of ganaxolone IV, an intravenous (IV) formulation of Marinus' CNS-selective GABAA modulator, for the treatment of status epilepticus (SE). The study is designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of ganaxolone IV in healthy volunteers, with data anticipated in the second half of 2016.


The Phase 1 study, which will be conducted at Duke University Medical Center, will include a dose escalation of a bolus dosage of ganaxolone IV and a bolus dose of ganaxolone IV, followed by a continuous infusion. The primary study objective is to evaluate the safety and PK of ganaxolone IV. The secondary study objectives include the PD effects of ganaxolone IV on electroencephalogram (EEG) parameters and ventilation, as well as the effect of ganaxolone IV on clinical sedation scores.