A Phase 1 interventional study of Original formulation EMB-001 and New formulation EMB-001 in Cocaine Use Disorder, sponsored by Embera NeuroTherapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-11.
Sponsored by Embera NeuroTherapeutics, Inc. · Phase 1, Interventional, and Other
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
Adequate organ function at screening as defined by:
Exclusion Criteria:
Subjects will receive investigational product (IP) once each Period as a single dose under fasted or fed conditions as follows: Period 1: EMB-001 new formulation under fed condition Period 2: EMB-001 new formulation under fasted conditions Period 3: EMB-001 original formulation under fed conditions
Drug: Original formulation EMB-001 · Drug: New formulation EMB-001
Subjects will receive investigational product (IP) once each Period as a single dose under fasted or fed conditions as follows: Period 1: EMB-001 original formulation under fed conditions Period 2: EMB-001 new formulation under fed conditions Period 3: EMB-001 new formulation under fasted conditions
Drug: Original formulation EMB-001 · Drug: New formulation EMB-001
Subjects will receive investigational product (IP) once each Period as a single dose under fasted or fed conditions as follows: Period 1: EMB-001 new formulation under fasted conditions Period 2: EMB-001 original formulation under fed conditions Period 3: EMB-001 new formulation under fed conditions
Drug: Original formulation EMB-001 · Drug: New formulation EMB-001
Single oral dose (720 mg metyrapone/24 mg oxazepam)
Single oral dose (720 mg metyrapone/24 mg oxazepam)
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of EMB-001
The AUC0-inf is calculated in a plot of concentration of drug in blood plasma against time and extrapolated to infinity.
Time frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post drug administration in each Period.
Maximum Observed Concentration (Cmax) of EMB-001
Cmax is the maximum observed concentration of drug in blood plasma.
Time frame: Periods 1-3, pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post drug administration in each Period.
Time to Maximum Concentration (Tmax) of EMB-001
Tmax is the time elapsed from the time of drug administration to maximum plasma concentration.
Time frame: Periods 1-3, pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post drug administration in each Period.
Apparent Half-Life (t1/2) of EMB-001
Half-life is defined as the time required for the drug plasma concentration to be reduced to half.
Time frame: Periods 1-3, pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post drug administration in each Period.
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.
Time frame: 21 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Embera NeuroTherapeutics, Inc.