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| ID | Type | Description | Link |
|---|---|---|---|
| U01DA038879 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Institute on Drug Abuse (NIDA) | NIH |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Active Comparator | 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 |
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| Sequence 2 | Active Comparator | 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 |
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| Sequence 3 | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Original formulation EMB-001 | Drug | Single oral dose (720 mg metyrapone/24 mg oxazepam) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 21 days |
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Inclusion Criteria:
Provide written informed consent prior to any study procedures.
Age 18 to 60 and able to read and write English
Females must be of non-childbearing potential. Evidence of non-childbearing potential includes documented surgical sterilization (hysterectomy or bilateral oophorectomy) or being postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over age 45 in the absence of other biological or physiological cause. In addition, women must have a documented serum follicle stimulating hormone (FSH) level >40 mIU/mL.
Light smokers (<10 cigarettes per day), non-smokers, or ex-smokers
Body mass index ≥18.5 and <30 kg/m2
Able to take oral medications and willing to adhere to medication regimen during the study
No clinically relevant abnormal physical findings at the Screening examination
Electrocardiogram without clinically significant abnormality at Screening
Normal blood pressure (BP) and heart rate (systolic BP 90 to 140 mmHg; diastolic BP 50 to 90 mmHg; heart rate 50 to 100 beats per minute)
No clinically relevant abnormal laboratory findings (general biochemistry, hematology, urinalysis, endocrinology [cortisol]) at Screening
Adequate organ function at screening as defined by:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mike Detke, MD | Embera NeuroTherapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Collaborative Neuroscience Network, LLC | Long Beach | California | 90806 | United States |
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3-period, 3-sequence crossover evaluating 3 treatments
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| New formulation EMB-001 | Drug | Single oral dose (720 mg metyrapone/24 mg oxazepam) |
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