A PHASE I, OPEN-LABEL, FIXED-SEQUENCE, THREE-PERIOD CROSSOVER TRIAL TO EVALUATE THE PHARMACOKINETICS OF TWO DIFFERENT TABLET FORMULATIONS OF BCI 952 COMPARED TO THE OVER-ENCAPSULATED BCI-952 PRODUCT COMPONENTS IN HEALTHY MALE SUBJECTS - BCI-952 three-period crossover bioequivalence study
An Open-Label Extension Study to Assess the Tolerability of BCI-024 in Combination With BCI-049 in Patients With Major Depressive Disorder
The objective of this study is to allow patients who have participated in the precursor study of BCI-024 in combination with BCI-049 versus placebo or BCI-024 alone (Protocol #CBM-IT-01) to receive 6 weeks of open-label treatment with an increased dose of BCI-024 in combination with an increased dose of BCI-049. The safety and tolerability of this higher dose of the combination will be evaluated, as will the treatment effect in reducing symptoms of depression in patients with MDD.