NCT02856854

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

A Phase 1b, Randomized, Double-Blinded, Multiple-Dose, Placebo Controlled, Crossover Study To Evaluate The Safety, Tolerability And Pharmacokinetic Effects Of A Metyrapone And Oxazepam Combination (EMB-001) When Co-Administered With Cocaine

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Embera NeuroTherapeutics, Inc. · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single center, randomized, double-blinded, multiple-dose, PLB controlled, 2-period, 4-sequence, crossover study design. After establishing eligibility approximately 16 subjects with cocaine use disorder will be randomized to one of four sequences. Treatment periods will be separated by a 7-day in-patient washout period. EMB-001/PLB will be orally administered for 7 consecutive days, BID for 6 days (starting on Day 1 and Day 15) followed on the last day (Day 7 and Day 21) by one EMB-001/PLB oral dose in the morning. Infusion of 40 mg IV cocaine and IV saline-to-match cocaine infusion will be administered in a randomized order, 2 hours apart, starting 3 hours after the last morning EMB-001/PLB oral administration. The subjects will be discharged from the research clinic 2 days after the last dose of cocaine, and will have a follow-up visit 7 days after last dose.

Conditions

• Cocaine Use Disorder

Interventions

Type	Name	Description
DRUG	EMB-001	EMB-001 is a combination of metyrapone (720mg per dose in this study) and oxazepam (24mg per dose in this study)
DRUG	Placebo	EMB-001 matched placebo
DRUG	Cocaine IV	Cocaine administered at doses of 20 and 40mg
DRUG	Saline IV	Cocaine matched placebo

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-02-17
• Completion: 2017-07-25
• First posted: 2016-08-05
• Last updated: 2017-08-01

Locations

1 site across 1 country: United States