NCT03404817

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Embera NeuroTherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Conditions

• Cocaine Use Disorder

Interventions

Type	Name	Description
DRUG	Original formulation EMB-001	Single oral dose (720 mg metyrapone/24 mg oxazepam)
DRUG	New formulation EMB-001	Single oral dose (720 mg metyrapone/24 mg oxazepam)

Timeline

• Start date: 2018-03-01
• Primary completion: 2018-06-07
• Completion: 2018-06-07
• First posted: 2018-01-19
• Last updated: 2018-06-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study