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

NCT03404817 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2018-06-11

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Embera NeuroTherapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Mike Detke, MD · Embera NeuroTherapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2018-06-07
Completion
2018-06-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03404817 on ClinicalTrials.gov