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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
18
EMB-001 is a combination of metyrapone (720mg per dose in this study) and oxazepam (24mg per dose in this study)
EMB-001 matched placebo
Cocaine administered at doses of 20 and 40mg
Vince & Associates
Overland Park, Kansas, United States
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Adverse event data (including clinically significant changes in laboratory values) will be compiled for EMB-001 and placebo cohorts.
Time frame: 29 Days
Vital signs
Blood Pressure (BP) and heart rate (HR) measures during saline infusions will be compared to HR and BP after cocaine infusion (40 mg). Changes in BP and HR induced by cocaine infusion along with EMB-001 will be compared to those with EMB-001-matched placebo.
Time frame: 29 days
ECGs
Changes in ECG readings during saline infusion will be compared to those taken during cocaine infusion along with EMB-001 will be compared to those with EMB-001-matched placebo.
Time frame: 29 days
PK Parameter EMB-001
Cmax (maximum concentration) of EMB-001 will be compared when taken alone and when taken with cocaine
Time frame: 21 days
PK Parameter Cocaine
Cmax (maximum concentration) of cocaine will be compared when taken alone and when taken with EMB-001
Time frame: 21 days
PK Parameter EMB-001
AUC (area under the curve) of EMB-001 will be compared when taken alone and when taken with cocaine
Time frame: 21 days
PK Parameter Cocaine
AUC (area under the curve) of Cocaine will be compared when taken alone and when taken with EMB-001
Time frame: 21 days
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Cocaine matched placebo