Embera NeuroTherapeutics, Inc.

This open-label study will evaluate EMB-001, comprised of metyrapone, a cortisol synthesis inhibitor marketed as a diagnostic drug for testing hypothalamic-pituitary-adrenal (HPA) axis function, combined with oxazepam, an anxiolytic and sedative/hypnotic benzodiazepine, to help smokers abstain from smoking during a 12-week trial period.

EMB-001 is a combination of 2 drugs: the cortisol synthesis inhibitor, metyrapone (Metopirone®), and the benzodiazepine receptor agonist, oxazepam (original trade name Serax®; now marketed as oxazepam (generic) only).
This is a Phase 2 study in approximately 80 adult subjects with moderate-to-severe Cocaine Use Disorder (CUD).

This is a study of EMB-001 (a combination of two FDA-approved drugs, metyrapone and oxazepam) in healthy adults.This is a Phase 1, single dose, 3-period, 3-sequence, crossover study in 9 healthy male and female (not of childbearing potential) volunteers. The study will evaluate the bioavailability and food effect of a new formulation of EMB-001 relative to the original formulation of EMB 001.
During the study, a total of 9 eligible subjects will be randomized in a 1:1:1 ratio to each of 3 treatment sequences