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Last Updated: August 8, 2020

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CLINICAL TRIALS PROFILE FOR METYRAPONE

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505(b)(2) Clinical Trials for Metyrapone

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT03404817 Single Dose Crossover Comparative Bioavailability and Food Effect Study of Two EMB-001 Formulations Completed National Institute on Drug Abuse (NIDA) Phase 1 2018-03-01 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
New Formulation NCT03404817 Single Dose Crossover Comparative Bioavailability and Food Effect Study of Two EMB-001 Formulations Completed Embera NeuroTherapeutics, Inc. Phase 1 2018-03-01 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
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Metyrapone

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00006270 Study of the Approximate Entropy of Adrenocorticotropic Hormone and Cortisol Secretion in Patients With Head Injury Unknown status University of Texas N/A 1998-02-01 OBJECTIVES: I. Determine the randomness of adrenocorticotropic hormone (ACTH) and cortisol secretion using approximate entropy in patients who have sustained a head injury. II. Determine the correlation between randomness of ACTH and cortisol secretion and stages of sleep in these patients.
NCT00006270 Study of the Approximate Entropy of Adrenocorticotropic Hormone and Cortisol Secretion in Patients With Head Injury Unknown status National Center for Research Resources (NCRR) N/A 1998-02-01 OBJECTIVES: I. Determine the randomness of adrenocorticotropic hormone (ACTH) and cortisol secretion using approximate entropy in patients who have sustained a head injury. II. Determine the correlation between randomness of ACTH and cortisol secretion and stages of sleep in these patients.
NCT00033098 Cocaine-Metyrapone Interaction Study - 1 Unknown status Cincinnati VA Medical Center Phase 1 2001-11-01 The purpose of this study is to examine the safety of two consecutive days of metyrapone (MRP) in subjects who may use cocaine concurrently.
NCT00033098 Cocaine-Metyrapone Interaction Study - 1 Unknown status National Institute on Drug Abuse (NIDA) Phase 1 2001-11-01 The purpose of this study is to examine the safety of two consecutive days of metyrapone (MRP) in subjects who may use cocaine concurrently.
NCT00125554 Metyrapone as Additive Treatment in Major Depression Completed Universitätsklinikum Hamburg-Eppendorf Phase 2 1998-05-01 The purpose of this study is to test whether metyrapone is an effective and safe augmenting agent in the treatment of major depression.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Metyrapone

Condition Name

Condition Name for Metyrapone
Intervention Trials
Cocaine Use Disorder 3
Alcohol Dependence 1
Steroid Suppression of ACTH Secretion 1
Cocaine-Related Disorders 1
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Condition MeSH

Condition MeSH for Metyrapone
Intervention Trials
Depressive Disorder 3
Depression 3
Syndrome 2
Cocaine-Related Disorders 2
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Clinical Trial Locations for Metyrapone

Trials by Country

Trials by Country for Metyrapone
Location Trials
United States 10
United Kingdom 4
France 2
Germany 1
Australia 1
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Trials by US State

Trials by US State for Metyrapone
Location Trials
California 2
Louisiana 2
Ohio 2
Kansas 1
Michigan 1
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Clinical Trial Progress for Metyrapone

Clinical Trial Phase

Clinical Trial Phase for Metyrapone
Clinical Trial Phase Trials
Phase 4 3
Phase 3 2
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Metyrapone
Clinical Trial Phase Trials
Completed 7
Recruiting 3
Unknown status 3
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Clinical Trial Sponsors for Metyrapone

Sponsor Name

Sponsor Name for Metyrapone
Sponsor Trials
National Institute on Drug Abuse (NIDA) 4
Embera NeuroTherapeutics, Inc. 4
Eli Lilly and Company 1
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Sponsor Type

Sponsor Type for Metyrapone
Sponsor Trials
Other 10
Industry 7
NIH 6
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