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Standard food-effect study to identify the effect of food on ecopipam pharmacokinetics after administration of a to-be-marketed ecopipam tablet in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dosed in fasted state | Other | Ecopipam will be taken in the morning in a fasted state |
|
| Dosed in fed state | Other | Ecopipam will be taken in the morning after a standard high-fat breakfast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ecopipam tablet | Drug | A single ecopipam 89.6 mg tablet (equivalent to ecopipam HCl 100 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of ecopipam after administration of an ecopipam tablet in the fed state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| Tmax of ecopipam after administration of an ecopipam tablet in the fed state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| AUC of ecopipam after administration of an ecopipam tablet in the fed state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| AUCinf of ecopipam after administration of an ecopipam tablet in the fed state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| AUClast of ecopipam after administration of an ecopipam tablet in the fed state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| Cmax of ecopipam after administration of an ecopipam tablet in the fasted state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| Tmax of ecopipam after administration of an ecopipam tablet in the fasted state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of EBS-101-40853 after administration of an ecopipam tablet in the fed state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| Tmax of EBS-101-40853 after administration of an ecopipam tablet in the fed state |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederick Munschauer, MSc, MD, FAAN | Emalex Biosciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Early Phase Services | San Antonio | Texas | 78209 | United States |
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| ID | Term |
|---|---|
| C058081 | ecopipam |
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| Up to Day 13 |
| AUC of ecopipam after administration of an ecopipam tablet in the fasted state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| AUClast of ecopipam after administration of an ecopipam tablet in the fasted state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| AUCinf of ecopipam after administration of an ecopipam tablet in the fasted state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis |
| Up to Day 13 |
| AUClast of EBS-101-40853 after administration of an ecopipam tablet in the fed state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| AUCinf of EBS-101-40853 after administration of an ecopipam tablet in the fed state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| Cmax of EBS-101-40853 after administration of an ecopipam tablet in the fasted state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| Tmax of EBS-101-40853 after administration of an ecopipam tablet in the fasted state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| AUClast of EBS-101-40853 after administration of an ecopipam tablet in the fasted state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| AUCinf of EBS-101-40853 after administration of an ecopipam tablet in the fasted state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| Cmax of ecopipam glucuronide after administration of an ecopipam tablet in the fed state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| Tmax of ecopipam glucuronide after administration of an ecopipam tablet in the fed state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| AUClast of ecopipam glucuronide after administration of an ecopipam tablet in the fed state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| AUCinf of ecopipam glucuronide after administration of an ecopipam tablet in the fed state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| Cmax of ecopipam glucuronide after administration of an ecopipam tablet in the fasted state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| Tmax of ecopipam glucuronide after administration of an ecopipam tablet in the fasted state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| AUClast of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fasted state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| AUCinf of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fasted state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| Cmax of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fed state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| Tmax of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fed state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| AUClast of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fed state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| AUCinf of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fed state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| Cmax of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fasted state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| Tmax of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fasted state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| AUClast of ecopipam glucuronide after administration of an ecopipam tablet in the fasted state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| AUCinf of ecopipam glucuronide after administration of an ecopipam tablet in the fasted state | Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 13 |
| Safety and tolerability as demonstrated by concomitant medications | Safety and tolerability measures will be recorded at the indicated timepoints | Up to Day 20 |
| Safety and tolerability as demonstrated by physical exams | Safety and tolerability measures will be recorded at the indicated timepoints | Up to Day 20 |
| Safety and tolerability as demonstrated by AEs | Subjects will be continually monitored for adverse events | Up to Day 20 |
| Systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHG) | Safety and tolerability measures will be recorded at the indicated timepoints | Up to Day 20 |
| Respiratory rate (breaths/minute) | Safety and tolerability measures will be recorded at the indicated timepoints | Up to Day 20 |
| Oral temperature (degrees Celsius) | Safety and tolerability measures will be recorded at the indicated timepoints | Up to Day 20 |
| Electrocardiogram (ECG) parameters: HR, PR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) (Milliseconds) | Safety and tolerability measures will be recorded at the indicated timepoints | Up to Day 20 |
| Values of white blood cell (WBC), neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelets (1000/mm3) | Safety and tolerability measures will be recorded at the indicated timepoints | Up to Day 20 |
| Value of hematocrit (percent) | Safety and tolerability measures will be recorded at the indicated timepoints | Up to Day 20 |
| Value of hemoglobin (g/dL) | Safety and tolerability measures will be recorded at the indicated timepoints | Up to Day 20 |
| Red blood cell (RBC) count (M/mm3) | Safety and tolerability measures will be recorded at the indicated timepoints | Up to Day 20 |
| Values of bicarbonate, sodium, magnesium, potassium, chloride (mmol/L) | Safety and tolerability measures will be recorded at the indicated timepoints | Up to Day 20 |
| Values of urea, phosphorus, calcium, glucose, total cholesterol, HDL, LDL, triglycerides, uric acid, and total, direct and indirect bilirubin (mg/dL) | Safety and tolerability measures will be recorded at the indicated timepoints | Up to Day 20 |
| Values of albumin and total protein (g/dL) | Safety and tolerability measures will be recorded at the indicated timepoints | Up to Day 20 |
| Values of amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST),alkaline phosphatase (ALP), creatine phosphokinase (CPK), and creatinine (U/L) | Safety and tolerability measures will be recorded at the indicated timepoints | Up to Day 20 |
| Value of urine pH | Safety and tolerability measures will be recorded at the indicated timepoints | Up to Day 20 |
| Value of urine glucose | Safety and tolerability measures will be recorded at the indicated timepoints | Up to Day 20 |
| Value of urine protein | Safety and tolerability measures will be recorded at the indicated timepoints | Up to Day 20 |
| Value of urine blood | Safety and tolerability measures will be recorded at the indicated timepoints | Up to Day 20 |
| Value of urine leukocyte esterase by dipstick | Safety and tolerability measures will be recorded at the indicated timepoints | Up to Day 20 |