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| Name | Class |
|---|---|
| Syneos Health | OTHER |
| Nuventra, Inc. | INDUSTRY |
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This is a single center, open-label, fixed sequence, drug-drug interaction (DDI) study in healthy subjects.
Following a 28-day Screening period, eligible subjects will enter the clinical research unit (CRU) and will be enrolled into either Cohort A or B. Subjects in both cohorts will receive a single dose of ecopipam on Day 1. On Day 7, subjects will begin taking a UGT inhibitor according to their assigned cohort. Subjects in Cohort A will receive mefenamic acid 250 mg every 6 hours for 7 days, while subjects in Cohort B will receive divalproex sodium ER 1250 mg once a day for 10 days. A single oral dose of ecopipam will also be administered to Cohort A on Day 7, 1 hour after the first dose of mefenamic acid, and to Cohort B on Day 10, 1 hour after administration of divalproex sodium ER. Subjects in Cohort A will continue taking mefenamic acid through the evening of Day 13 and will remain in the CRU until discharged on Day 14/ET. Subjects in Cohort B will continue taking divalproex sodium ER through Day 16 and will remain in the CRU until discharge on Day 17/ET.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Other | Ecopipam HCL - 2 doses of 200mg Mefenamic acid 250mg Q6H for 7 days |
|
| Cohort B | Other | Ecopipam HCL - 2 doses of 200mg Divalproex acid 1250mg QD for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ecopipam HCL | Drug | oral tablets |
| |
| Mefenamic acid |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| AUCinf of EBS-101-40853 | Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syneos Health Clinical Research Services, LLC. | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D008528 | Mefenamic Acid |
| ID | Term |
|---|---|
| D054361 | Fenamates |
| D062367 | ortho-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
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| Drug |
oral capsules |
|
| Divalproex Sodium ER | Drug | oral tablets |
|
| Up to Day 16 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Up to Day 16 |
| 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 |
| Cmax of mefenamic acid | Up to 15 blood samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 16 |
| Tmax of mefenamic acid | Up to 15 blood samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 16 |
| AUCtau of mefenamic acid | Up to 15 blood samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 16 |
| t½ of mefenamic acid | Up to 15 blood samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 16 |
| Cmax of VPA | Up to 19 blood samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 16 |
| Tmax of VPA | Up to 19 blood samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 16 |
| AUCtau of VPA | Up to 19 blood samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 16 |
| Safety and tolerability as demonstrated by MOAA/S | Safety and tolerability measures will be recorded at the indicated timepoints. | Up to Day 17 |
| Safety and tolerability as demonstrated by C-SSRS | Safety and tolerability measures will be recorded at the indicated timepoints. | Up to Day 17 |
| Safety and tolerability as demonstrated by concomitant medications | Safety and tolerability measures will be recorded at the indicated timepoints. | Up to Day 42 |
| AEs with relatedness associated with mefenamic acid | Subjects will be continually monitored for adverse events | Up to Day 42 |
| AEs with relatedness associated with divalproex sodium ER | Subjects will be continually monitored for adverse events | Up to Day 42 |
| AEs with relatedness associated with ecopipam | Subjects will be continually monitored for adverse events | Up to Day 42 |
| 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 |
| 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 |
| Absolute values of platelets (K/uL) | Blood samples will be collected for the assessment of hematology parameters. | Up to Day 17 |
| Absolute values of hematocrit (%) | Blood samples will be collected for the assessment of hematology parameters. | Up to Day 17 |
| Absolute values of hemoglobin (g/dL) | Blood samples will be collected for the assessment of hematology parameters. | Up to Day 17 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Absolute values of urine specific gravity | Urine samples will be collected for the assessment of urine parameters. | Up to Day 17 |
| Absolute values of urine pH | Urine samples will be collected for the assessment of urine parameters. | Up to Day 17 |
| Absolute values of urine glucose | Urine samples will be collected for the assessment of urine parameters. | Up to Day 17 |
| Absolute values of urine protein | Urine samples will be collected for the assessment of urine parameters. | Up to Day 17 |
| Absolute values of urine blood | Urine samples will be collected for the assessment of urine parameters. | Up to Day 17 |
| Absolute values of urine ketones | Urine samples will be collected for the assessment of urine parameters. | Up to Day 17 |
| Absolute values of urine bilirubin, urobilinogen, and nitrite | Urine samples will be collected for the assessment of urine parameters. | Up to Day 17 |
| Absolute values of urine leukocytes by dipstick | Urine samples will be collected for the assessment of urine parameters. | Up to Day 17 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Absolute values of oral temperature (degrees Celsius) | Temperature will be assessed as part of vital signs. | Up to Day 17 |
| 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 |
| Absolute values of heart rate (beats/minute) | Heart rate will be assessed as part of vital signs. | Up to Day 17 |
| 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 |
| Absolute values of respiratory rate (breaths/minute) | Respiratory rate will be assessed as part of vital signs. | Up to Day 17 |
| 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 |
| 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 |
| 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 |
| D000146 |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |