Single Dose Crossover Comparative Bioavailability and Food Effect Study of Two EMB-001 Formulations

Summary

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

Timeline

Start

2018-03-01

Primary completion

2018-06-07

Completion

2018-06-07

Drugs

Indications