Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Cmax of ecopipam in the presence of mefenamic acid |
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis |
Up to Day 16 |
|
Primary |
Cmax of ecopipam in the absence of mefenamic acid |
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis |
Up to Day 16 |
|
Primary |
Cmax of ecopipam in the presence of divalproex sodium ER |
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis |
Up to Day 16 |
|
Primary |
Cmax of ecopipam in the absence of divalproex sodium ER |
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis |
Up to Day 16 |
|
Primary |
AUCinf of ecopipam in the presence of mefenamic acid |
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis |
Up to Day 16 |
|
Primary |
AUCinf of ecopipam in the absence of mefenamic acid |
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis |
Up to Day 16 |
|
Primary |
AUCinf of ecopipam in the presence of divalproex sodium ER |
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis |
Up to Day 16 |
|
Primary |
AUCinf of ecopipam in the absence of divalproex sodium ER |
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis |
Up to Day 16 |
|
Primary |
AUC0-143 of ecopipam in the presence of mefenamic acid |
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis |
Up to Day 16 |
|
Primary |
AUC0-143 of ecopipam in the absence of mefenamic acid |
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis |
Up to Day 16 |
|
Primary |
AUC0-143 of ecopipam in the presence of divalproex sodium ER |
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis |
Up to Day 16 |
|
Primary |
AUC0-143 of ecopipam in the absence of divalproex sodium ER |
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis |
Up to Day 16 |
|
Secondary |
Cmax of EBS-101-40853 |
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis |
Up to Day 16 |
|
Secondary |
AUCinf of EBS-101-40853 |
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis |
Up to Day 16 |
|
Secondary |
AUC0-143 of EBS-101-40853 |
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis |
Up to Day 16 |
|
Secondary |
Cmax of mefenamic acid |
Up to 15 blood samples will be collected at the indicated time points for pharmacokinetic analysis |
Up to Day 16 |
|
Secondary |
Tmax of mefenamic acid |
Up to 15 blood samples will be collected at the indicated time points for pharmacokinetic analysis |
Up to Day 16 |
|
Secondary |
AUCtau of mefenamic acid |
Up to 15 blood samples will be collected at the indicated time points for pharmacokinetic analysis |
Up to Day 16 |
|
Secondary |
t½ of mefenamic acid |
Up to 15 blood samples will be collected at the indicated time points for pharmacokinetic analysis |
Up to Day 16 |
|
Secondary |
Cmax of VPA |
Up to 19 blood samples will be collected at the indicated time points for pharmacokinetic analysis |
Up to Day 16 |
|
Secondary |
Tmax of VPA |
Up to 19 blood samples will be collected at the indicated time points for pharmacokinetic analysis |
Up to Day 16 |
|
Secondary |
AUCtau of VPA |
Up to 19 blood samples will be collected at the indicated time points for pharmacokinetic analysis |
Up to Day 16 |
|
Secondary |
Safety and tolerability as demonstrated by MOAA/S |
Safety and tolerability measures will be recorded at the indicated timepoints. |
Up to Day 17 |
|
Secondary |
Safety and tolerability as demonstrated by C-SSRS |
Safety and tolerability measures will be recorded at the indicated timepoints. |
Up to Day 17 |
|
Secondary |
Safety and tolerability as demonstrated by concomitant medications |
Safety and tolerability measures will be recorded at the indicated timepoints. |
Up to Day 42 |
|
Secondary |
AEs with relatedness associated with mefenamic acid |
Subjects will be continually monitored for adverse events |
Up to Day 42 |
|
Secondary |
AEs with relatedness associated with divalproex sodium ER |
Subjects will be continually monitored for adverse events |
Up to Day 42 |
|
Secondary |
AEs with relatedness associated with ecopipam |
Subjects will be continually monitored for adverse events |
Up to Day 42 |
|
Secondary |
Absolute values of white blood cell (WBC) count (K/Ul) |
Blood samples will be collected for the assessment of hematology parameters. |
Up to Day 17 |
|
Secondary |
Absolute values of neutrophils, lymphocytes, monocytes, eosinophils, and basophils (10E3/uL) |
Blood samples will be collected for the assessment of hematology parameters. |
Up to Day 17 |
|
Secondary |
Absolute values of platelets (K/uL) |
Blood samples will be collected for the assessment of hematology parameters. |
Up to Day 17 |
|
Secondary |
Absolute values of hematocrit (%) |
Blood samples will be collected for the assessment of hematology parameters. |
Up to Day 17 |
|
Secondary |
Absolute values of hemoglobin (g/dL) |
Blood samples will be collected for the assessment of hematology parameters. |
Up to Day 17 |
|
Secondary |
Absolute values of Red blood cell (RBC) count (M/uL) |
Blood samples will be collected for the assessment of hematology parameters. |
Up to Day 17 |
|
Secondary |
Absolute values of blood sodium, magnesium, urea, phosphorus, potassium, and chloride (mg/dL) |
Blood samples will be collected for the assessment of clinical chemistry parameters. |
Up to Day 17 |
|
Secondary |
Absolute values of creatinine, calcium, glucose, and direct and total bilirubin (mg/dL) |
Blood samples will be collected for the assessment of clinical chemistry parameters. |
Up to Day 17 |
|
Secondary |
Absolute values of albumin and total protein (g/dL) |
Blood samples will be collected for the assessment of clinical chemistry parameters. |
Up to Day 17 |
|
Secondary |
Absolute values of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), and creatinine phosphokinase (CPK) |
Blood samples will be collected for the assessment of clinical chemistry parameters. |
Up to Day 17 |
|
Secondary |
Absolute values of urine specific gravity |
Urine samples will be collected for the assessment of urine parameters. |
Up to Day 17 |
|
Secondary |
Absolute values of urine pH |
Urine samples will be collected for the assessment of urine parameters. |
Up to Day 17 |
|
Secondary |
Absolute values of urine glucose |
Urine samples will be collected for the assessment of urine parameters. |
Up to Day 17 |
|
Secondary |
Absolute values of urine protein |
Urine samples will be collected for the assessment of urine parameters. |
Up to Day 17 |
|
Secondary |
Absolute values of urine blood |
Urine samples will be collected for the assessment of urine parameters. |
Up to Day 17 |
|
Secondary |
Absolute values of urine ketones |
Urine samples will be collected for the assessment of urine parameters. |
Up to Day 17 |
|
Secondary |
Absolute values of urine bilirubin, urobilinogen, and nitrite |
Urine samples will be collected for the assessment of urine parameters. |
Up to Day 17 |
|
Secondary |
Absolute values of urine leukocytes by dipstick |
Urine samples will be collected for the assessment of urine parameters. |
Up to Day 17 |
|
Secondary |
Change from Day -1 to Day of Discharge in white blood cell (WBC) count (K/Ul) |
Blood samples will be collected for the assessment of hematology parameters. |
Up to Day 17 |
|
Secondary |
Change from Day -1 to Day of Discharge in neutrophils, lymphocytes, monocytes, eosinophils, and basophils (10E3/uL) |
Blood samples will be collected for the assessment of hematology parameters. |
Up to Day 17 |
|
Secondary |
Change from Day -1 to Day of Discharge in platelets (K/uL) |
Blood samples will be collected for the assessment of hematology parameters. |
Up to Day 17 |
|
Secondary |
Change from Day -1 to Day of Discharge in hematocrit (%) |
Blood samples will be collected for the assessment of hematology parameters. |
Up to Day 17 |
|
Secondary |
Change from Day -1 to Day of Discharge in hemoglobin (g/dL) |
Blood samples will be collected for the assessment of hematology parameters. |
Up to Day 17 |
|
Secondary |
Change from Day -1 to Day of Discharge in Red blood cell (RBC) count (M/uL) |
Blood samples will be collected for the assessment of hematology parameters. |
Up to Day 17 |
|
Secondary |
Change from Day -1 to Day of Discharge in blood sodium, magnesium, urea, phosphorus, potassium, and chloride (mg/dL) |
Blood samples will be collected for the assessment of clinical chemistry parameters. |
Up to Day 17 |
|
Secondary |
Change from Day -1 to Day of Discharge in creatinine, calcium, glucose, and direct and total bilirubin (mg/dL) |
Blood samples will be collected for the assessment of clinical chemistry parameters. |
Up to Day 17 |
|
Secondary |
Change from Day -1 to Day of Discharge in albumin and total protein (g/dL) |
Blood samples will be collected for the assessment of clinical chemistry parameters. |
Up to Day 17 |
|
Secondary |
Change from Day -1 to Day of Discharge in alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), and creatinine phosphokinase (CPK) (U/L) |
Blood samples will be collected for the assessment of clinical chemistry parameters. |
Up to Day 17 |
|
Secondary |
Change from Day -1 to Day of Discharge in urine specific gravity |
Urine samples will be collected for the assessment of urine parameters. |
Up to Day 17 |
|
Secondary |
Change from Day -1 to Day of Discharge in urine pH |
Urine samples will be collected for the assessment of urine parameters. |
Up to Day 17 |
|
Secondary |
Change from Day -1 to Day of Discharge in urine glucose |
Urine samples will be collected for the assessment of urine parameters. |
Up to Day 17 |
|
Secondary |
Change from Day -1 to Day of Discharge in urine protein |
Urine samples will be collected for the assessment of urine parameters. |
Up to Day 17 |
|
Secondary |
Change from Day -1 to Day of Discharge in urine blood |
Urine samples will be collected for the assessment of urine parameters. |
Up to Day 17 |
|
Secondary |
Change from Day -1 to Day of Discharge in urine ketones |
Urine samples will be collected for the assessment of urine parameters. |
Up to Day 17 |
|
Secondary |
Change from Day -1 to Day of Discharge in urine bilirubin, urobilinogen, and nitrite (Milligrams per deciliter) |
Urine samples will be collected for the assessment of urine parameters. |
Up to Day 17 |
|
Secondary |
Change from Day -1 to Day of Discharge in urine leukocytes by dipstick |
Urine samples will be collected for the assessment of urine parameters. |
Up to Day 17 |
|
Secondary |
Change from Day 6 to Day of Discharge in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) (U/L) |
Blood samples will be collected for the assessment of clinical chemistry parameters. |
Up to Day 17 |
|
Secondary |
Absolute values of electrocardiogram (ECG) parameters: PR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) (Milliseconds) |
Twelve-lead ECGs will be obtained with the participant in a supine position after a rest of at least 5 minutes using an automated ECG machine. PR, QRS, QT, and QTcF intervals will be measured. |
Up to Day 10 |
|
Secondary |
Change from pre-dose for the respective day in ECG parameters: PR, QRS, QT, and QTcF (Milliseconds) |
Twelve-lead ECGs will be obtained with the participant in a supine position after a rest of at least 5 minutes using an automated ECG machine. PR, QRS, QT, and QTcF intervals will be measured. |
Up to Day 10 |
|
Secondary |
Absolute values of oral temperature (degrees Celsius) |
Temperature will be assessed as part of vital signs. |
Up to Day 17 |
|
Secondary |
Change from pre-dose for the respective day in oral temperature (degrees Celsius) |
Temperature will be assessed as part of vital signs. |
Up to Day 17 |
|
Secondary |
Absolute values of heart rate (beats/minute) |
Heart rate will be assessed as part of vital signs. |
Up to Day 17 |
|
Secondary |
Change from pre-dose for the respective day in heart rate (beats/minute) |
Heart rate will be assessed as part of vital signs. |
Up to Day 17 |
|
Secondary |
Absolute values of respiratory rate (breaths/minute) |
Respiratory rate will be assessed as part of vital signs. |
Up to Day 17 |
|
Secondary |
Change from pre-dose for the respective day in respiratory rate (breaths/minute) |
Respiratory rate will be assessed as part of vital signs. |
Up to Day 17 |
|
Secondary |
Absolute values of systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHG) |
Blood pressure will be assessed as part of vital signs. |
Up to Day 17 |
|
Secondary |
Change from pre-dose for the respective day in SBP and DBP (mmHG) |
Blood pressure will be assessed as part of vital signs. |
Up to Day 17 |
|