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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
9
Single oral dose (720 mg metyrapone/24 mg oxazepam)
Single oral dose (720 mg metyrapone/24 mg oxazepam)
Collaborative Neuroscience Network, LLC
Long Beach, California, United States
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
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