A Study of Metyrapone and Oxazepam Combination Product (EMB-001) and Cocaine

• Status: Completed
• Trial end date: 2017-07-25
• Target enrollment: 0
• Participant gender: All

Summary

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 Phase 1b cocaine interaction study is being conducted in order to assess the safety and PK of EMB-001 and cocaine in combination.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Embera NeuroTherapeutics, Inc.
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Cocaine; Metyrapone; Oxazepam

Criteria

Inclusion Criteria:

• non-treatment-seeking cocaine users with a positive urine toxicology screen for cocaine at least once during screening

• have a medical history and physical examination that demonstrate no clinically significant contraindication for participating in the study

• males must use contraception; females must be of non-childbearing potential

Exclusion Criteria:

• drug allergies or reactions to metyrapone or benzodiazepines, or severe hypersensitivity reactions (like angioedema) to any drugs

• history of clinically significant adverse reaction to cocaine

• a low out-of-range serum cortisol value at screening or subjects who have a heightened likelihood of having adrenal insufficiency, or have signs or a history of adrenal insufficiency or confounders of the levels of cortisol and/or cortisol binding globulin

• treatment with glucocorticoids

• history of seizures, benzodiazepine use disorder, respiratory disease, neurologic or neuromuscular disease, liver disease or cardiovascular disease

• other psychiatric or substance use disorders of clinical significance, or suicidality

• clinically significant finding on medical history, physical examination, clinical laboratory tests, vital signs or ECGs

• use of any other drugs

• abnormal BP or HR

• positive urine drug screen at for alcohol or any drug other than marijuana (THC) or cocaine

• positive serology test results for HIV-1/HIV-2 Antibodies, Hepatitis B surface Antigen (HBsAg) or Hepatitis C Antibody (HCVAb)