Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT04902105
Status:
COMPLETED
Last Update Posted:
2021-07-22
First Post:
2021-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Drug-Drug Interaction Study to Evaluate the Effect of Inhibition of UGTs on the PK of Ecopipam and Its Active Metabolite
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008528', 'term': 'Mefenamic Acid'}], 'ancestors': [{'id': 'D054361', 'term': 'Fenamates'}, {'id': 'D062367', 'term': 'ortho-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-20', 'studyFirstSubmitDate': '2021-05-20', 'studyFirstSubmitQcDate': '2021-05-20', 'lastUpdatePostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax of ecopipam in the presence of mefenamic acid', 'timeFrame': 'Up to Day 16', 'description': 'Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'Cmax of ecopipam in the absence of mefenamic acid', 'timeFrame': 'Up to Day 16', 'description': 'Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'Cmax of ecopipam in the presence of divalproex sodium ER', 'timeFrame': 'Up to Day 16', 'description': 'Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'Cmax of ecopipam in the absence of divalproex sodium ER', 'timeFrame': 'Up to Day 16', 'description': 'Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'AUCinf of ecopipam in the presence of mefenamic acid', 'timeFrame': 'Up to Day 16', 'description': 'Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'AUCinf of ecopipam in the absence of mefenamic acid', 'timeFrame': 'Up to Day 16', 'description': 'Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'AUCinf of ecopipam in the presence of divalproex sodium ER', 'timeFrame': 'Up to Day 16', 'description': 'Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'AUCinf of ecopipam in the absence of divalproex sodium ER', 'timeFrame': 'Up to Day 16', 'description': 'Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'AUC0-143 of ecopipam in the presence of mefenamic acid', 'timeFrame': 'Up to Day 16', 'description': 'Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'AUC0-143 of ecopipam in the absence of mefenamic acid', 'timeFrame': 'Up to Day 16', 'description': 'Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'AUC0-143 of ecopipam in the presence of divalproex sodium ER', 'timeFrame': 'Up to Day 16', 'description': 'Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'AUC0-143 of ecopipam in the absence of divalproex sodium ER', 'timeFrame': 'Up to Day 16', 'description': 'Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}], 'secondaryOutcomes': [{'measure': 'Cmax of EBS-101-40853', 'timeFrame': 'Up to Day 16', 'description': 'Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'AUCinf of EBS-101-40853', 'timeFrame': 'Up to Day 16', 'description': 'Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'AUC0-143 of EBS-101-40853', 'timeFrame': 'Up to Day 16', 'description': 'Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'Cmax of mefenamic acid', 'timeFrame': 'Up to Day 16', 'description': 'Up to 15 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'Tmax of mefenamic acid', 'timeFrame': 'Up to Day 16', 'description': 'Up to 15 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'AUCtau of mefenamic acid', 'timeFrame': 'Up to Day 16', 'description': 'Up to 15 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 't½ of mefenamic acid', 'timeFrame': 'Up to Day 16', 'description': 'Up to 15 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'Cmax of VPA', 'timeFrame': 'Up to Day 16', 'description': 'Up to 19 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'Tmax of VPA', 'timeFrame': 'Up to Day 16', 'description': 'Up to 19 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'AUCtau of VPA', 'timeFrame': 'Up to Day 16', 'description': 'Up to 19 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'Safety and tolerability as demonstrated by MOAA/S', 'timeFrame': 'Up to Day 17', 'description': 'Safety and tolerability measures will be recorded at the indicated timepoints.'}, {'measure': 'Safety and tolerability as demonstrated by C-SSRS', 'timeFrame': 'Up to Day 17', 'description': 'Safety and tolerability measures will be recorded at the indicated timepoints.'}, {'measure': 'Safety and tolerability as demonstrated by concomitant medications', 'timeFrame': 'Up to Day 42', 'description': 'Safety and tolerability measures will be recorded at the indicated timepoints.'}, {'measure': 'AEs with relatedness associated with mefenamic acid', 'timeFrame': 'Up to Day 42', 'description': 'Subjects will be continually monitored for adverse events'}, {'measure': 'AEs with relatedness associated with divalproex sodium ER', 'timeFrame': 'Up to Day 42', 'description': 'Subjects will be continually monitored for adverse events'}, {'measure': 'AEs with relatedness associated with ecopipam', 'timeFrame': 'Up to Day 42', 'description': 'Subjects will be continually monitored for adverse events'}, {'measure': 'Absolute values of white blood cell (WBC) count (K/Ul)', 'timeFrame': 'Up to Day 17', 'description': 'Blood samples will be collected for the assessment of hematology parameters.'}, {'measure': 'Absolute values of neutrophils, lymphocytes, monocytes, eosinophils, and basophils (10E3/uL)', 'timeFrame': 'Up to Day 17', 'description': 'Blood samples will be collected for the assessment of hematology parameters.'}, {'measure': 'Absolute values of platelets (K/uL)', 'timeFrame': 'Up to Day 17', 'description': 'Blood samples will be collected for the assessment of hematology parameters.'}, {'measure': 'Absolute values of hematocrit (%)', 'timeFrame': 'Up to Day 17', 'description': 'Blood samples will be collected for the assessment of hematology parameters.'}, {'measure': 'Absolute values of hemoglobin (g/dL)', 'timeFrame': 'Up to Day 17', 'description': 'Blood samples will be collected for the assessment of hematology parameters.'}, {'measure': 'Absolute values of Red blood cell (RBC) count (M/uL)', 'timeFrame': 'Up to Day 17', 'description': 'Blood samples will be collected for the assessment of hematology parameters.'}, {'measure': 'Absolute values of blood sodium, magnesium, urea, phosphorus, potassium, and chloride (mg/dL)', 'timeFrame': 'Up to Day 17', 'description': 'Blood samples will be collected for the assessment of clinical chemistry parameters.'}, {'measure': 'Absolute values of creatinine, calcium, glucose, and direct and total bilirubin (mg/dL)', 'timeFrame': 'Up to Day 17', 'description': 'Blood samples will be collected for the assessment of clinical chemistry parameters.'}, {'measure': 'Absolute values of albumin and total protein (g/dL)', 'timeFrame': 'Up to Day 17', 'description': 'Blood samples will be collected for the assessment of clinical chemistry parameters.'}, {'measure': 'Absolute values of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), and creatinine phosphokinase (CPK)', 'timeFrame': 'Up to Day 17', 'description': 'Blood samples will be collected for the assessment of clinical chemistry parameters.'}, {'measure': 'Absolute values of urine specific gravity', 'timeFrame': 'Up to Day 17', 'description': 'Urine samples will be collected for the assessment of urine parameters.'}, {'measure': 'Absolute values of urine pH', 'timeFrame': 'Up to Day 17', 'description': 'Urine samples will be collected for the assessment of urine parameters.'}, {'measure': 'Absolute values of urine glucose', 'timeFrame': 'Up to Day 17', 'description': 'Urine samples will be collected for the assessment of urine parameters.'}, {'measure': 'Absolute values of urine protein', 'timeFrame': 'Up to Day 17', 'description': 'Urine samples will be collected for the assessment of urine parameters.'}, {'measure': 'Absolute values of urine blood', 'timeFrame': 'Up to Day 17', 'description': 'Urine samples will be collected for the assessment of urine parameters.'}, {'measure': 'Absolute values of urine ketones', 'timeFrame': 'Up to Day 17', 'description': 'Urine samples will be collected for the assessment of urine parameters.'}, {'measure': 'Absolute values of urine bilirubin, urobilinogen, and nitrite', 'timeFrame': 'Up to Day 17', 'description': 'Urine samples will be collected for the assessment of urine parameters.'}, {'measure': 'Absolute values of urine leukocytes by dipstick', 'timeFrame': 'Up to Day 17', 'description': 'Urine samples will be collected for the assessment of urine parameters.'}, {'measure': 'Change from Day -1 to Day of Discharge in white blood cell (WBC) count (K/Ul)', 'timeFrame': 'Up to Day 17', 'description': 'Blood samples will be collected for the assessment of hematology parameters.'}, {'measure': 'Change from Day -1 to Day of Discharge in neutrophils, lymphocytes, monocytes, eosinophils, and basophils (10E3/uL)', 'timeFrame': 'Up to Day 17', 'description': 'Blood samples will be collected for the assessment of hematology parameters.'}, {'measure': 'Change from Day -1 to Day of Discharge in platelets (K/uL)', 'timeFrame': 'Up to Day 17', 'description': 'Blood samples will be collected for the assessment of hematology parameters.'}, {'measure': 'Change from Day -1 to Day of Discharge in hematocrit (%)', 'timeFrame': 'Up to Day 17', 'description': 'Blood samples will be collected for the assessment of hematology parameters.'}, {'measure': 'Change from Day -1 to Day of Discharge in hemoglobin (g/dL)', 'timeFrame': 'Up to Day 17', 'description': 'Blood samples will be collected for the assessment of hematology parameters.'}, {'measure': 'Change from Day -1 to Day of Discharge in Red blood cell (RBC) count (M/uL)', 'timeFrame': 'Up to Day 17', 'description': 'Blood samples will be collected for the assessment of hematology parameters.'}, {'measure': 'Change from Day -1 to Day of Discharge in blood sodium, magnesium, urea, phosphorus, potassium, and chloride (mg/dL)', 'timeFrame': 'Up to Day 17', 'description': 'Blood samples will be collected for the assessment of clinical chemistry parameters.'}, {'measure': 'Change from Day -1 to Day of Discharge in creatinine, calcium, glucose, and direct and total bilirubin (mg/dL)', 'timeFrame': 'Up to Day 17', 'description': 'Blood samples will be collected for the assessment of clinical chemistry parameters.'}, {'measure': 'Change from Day -1 to Day of Discharge in albumin and total protein (g/dL)', 'timeFrame': 'Up to Day 17', 'description': 'Blood samples will be collected for the assessment of clinical chemistry parameters.'}, {'measure': '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)', 'timeFrame': 'Up to Day 17', 'description': 'Blood samples will be collected for the assessment of clinical chemistry parameters.'}, {'measure': 'Change from Day -1 to Day of Discharge in urine specific gravity', 'timeFrame': 'Up to Day 17', 'description': 'Urine samples will be collected for the assessment of urine parameters.'}, {'measure': 'Change from Day -1 to Day of Discharge in urine pH', 'timeFrame': 'Up to Day 17', 'description': 'Urine samples will be collected for the assessment of urine parameters.'}, {'measure': 'Change from Day -1 to Day of Discharge in urine glucose', 'timeFrame': 'Up to Day 17', 'description': 'Urine samples will be collected for the assessment of urine parameters.'}, {'measure': 'Change from Day -1 to Day of Discharge in urine protein', 'timeFrame': 'Up to Day 17', 'description': 'Urine samples will be collected for the assessment of urine parameters.'}, {'measure': 'Change from Day -1 to Day of Discharge in urine blood', 'timeFrame': 'Up to Day 17', 'description': 'Urine samples will be collected for the assessment of urine parameters.'}, {'measure': 'Change from Day -1 to Day of Discharge in urine ketones', 'timeFrame': 'Up to Day 17', 'description': 'Urine samples will be collected for the assessment of urine parameters.'}, {'measure': 'Change from Day -1 to Day of Discharge in urine bilirubin, urobilinogen, and nitrite (Milligrams per deciliter)', 'timeFrame': 'Up to Day 17', 'description': 'Urine samples will be collected for the assessment of urine parameters.'}, {'measure': 'Change from Day -1 to Day of Discharge in urine leukocytes by dipstick', 'timeFrame': 'Up to Day 17', 'description': 'Urine samples will be collected for the assessment of urine parameters.'}, {'measure': 'Change from Day 6 to Day of Discharge in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) (U/L)', 'timeFrame': 'Up to Day 17', 'description': 'Blood samples will be collected for the assessment of clinical chemistry parameters.'}, {'measure': "Absolute values of electrocardiogram (ECG) parameters: PR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) (Milliseconds)", 'timeFrame': 'Up to Day 10', 'description': '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.'}, {'measure': 'Change from pre-dose for the respective day in ECG parameters: PR, QRS, QT, and QTcF (Milliseconds)', 'timeFrame': 'Up to Day 10', 'description': '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.'}, {'measure': 'Absolute values of oral temperature (degrees Celsius)', 'timeFrame': 'Up to Day 17', 'description': 'Temperature will be assessed as part of vital signs.'}, {'measure': 'Change from pre-dose for the respective day in oral temperature (degrees Celsius)', 'timeFrame': 'Up to Day 17', 'description': 'Temperature will be assessed as part of vital signs.'}, {'measure': 'Absolute values of heart rate (beats/minute)', 'timeFrame': 'Up to Day 17', 'description': 'Heart rate will be assessed as part of vital signs.'}, {'measure': 'Change from pre-dose for the respective day in heart rate (beats/minute)', 'timeFrame': 'Up to Day 17', 'description': 'Heart rate will be assessed as part of vital signs.'}, {'measure': 'Absolute values of respiratory rate (breaths/minute)', 'timeFrame': 'Up to Day 17', 'description': 'Respiratory rate will be assessed as part of vital signs.'}, {'measure': 'Change from pre-dose for the respective day in respiratory rate (breaths/minute)', 'timeFrame': 'Up to Day 17', 'description': 'Respiratory rate will be assessed as part of vital signs.'}, {'measure': 'Absolute values of systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHG)', 'timeFrame': 'Up to Day 17', 'description': 'Blood pressure will be assessed as part of vital signs.'}, {'measure': 'Change from pre-dose for the respective day in SBP and DBP (mmHG)', 'timeFrame': 'Up to Day 17', 'description': 'Blood pressure will be assessed as part of vital signs.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Drug Interaction']}, 'descriptionModule': {'briefSummary': 'This is a single center, open-label, fixed sequence, drug-drug interaction (DDI) study in healthy subjects.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male subjects or female subjects of non-childbearing potential\n* ≥18 and ≤55 years of age at the time of consent\n* BMI \\>18.5 and \\<30 kg/m2 and a weight of ≥50 kg\n* Sexually active males must use a double barrier method of contraception during the study and for at least 90 days after the last dose of study drug\n* Male subjects must be willing not to donate sperm until 90 days following the last study drug administration\n\nExclusion Criteria:\n\n* Personal or family History of significant medical illness\n* Clinically significant abnormalities on screening tests/exams\n* History of or significant risk of committing suicide\n* Donation of plasma within 7 days prior to dosing\n* Donation or significant loss of blood within 30 days prior to the first dosing\n* Major surgery within 3 months or minor surgery within 1 month prior to admission\n* Use of prohibited prescription, over-the-counter medications or natural health products\n* Alcohol-based products 24 hours prior to admission\n* Female subjects who are currently pregnant or lactating\n* Use of tobacco or nicotine products within 3 months prior to Screening\n* Significant alcohol consumption\n* History of drug abuse within the previous 2 years, or a positive drug screen\n* History of allergy to study medications\n* Not suitable for study in the opinion of the Principal Investigator'}, 'identificationModule': {'nctId': 'NCT04902105', 'briefTitle': 'Drug-Drug Interaction Study to Evaluate the Effect of Inhibition of UGTs on the PK of Ecopipam and Its Active Metabolite', 'organization': {'class': 'INDUSTRY', 'fullName': 'Emalex Biosciences Inc.'}, 'officialTitle': "A Phase 1, Open-Label, Fixed Sequence, Drug-Drug Interaction Study to Evaluate the Effect of Inhibition of Uridine 5'-Diphosphate-glucuronosyltransferases (UGTs) on the Pharmacokinetics of Ecopipam Tablets and Its Active Metabolite (EBS-101-40853) in Healthy Subjects", 'orgStudyIdInfo': {'id': 'EBS-101-HV-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cohort A', 'description': 'Ecopipam HCL - 2 doses of 200mg\n\nMefenamic acid 250mg Q6H for 7 days', 'interventionNames': ['Drug: ecopipam HCL', 'Drug: Mefenamic acid']}, {'type': 'OTHER', 'label': 'Cohort B', 'description': 'Ecopipam HCL - 2 doses of 200mg\n\nDivalproex acid 1250mg QD for 10 days', 'interventionNames': ['Drug: ecopipam HCL', 'Drug: Divalproex Sodium ER']}], 'interventions': [{'name': 'ecopipam HCL', 'type': 'DRUG', 'description': 'oral tablets', 'armGroupLabels': ['Cohort A', 'Cohort B']}, {'name': 'Mefenamic acid', 'type': 'DRUG', 'description': 'oral capsules', 'armGroupLabels': ['Cohort A']}, {'name': 'Divalproex Sodium ER', 'type': 'DRUG', 'description': 'oral tablets', 'armGroupLabels': ['Cohort B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Syneos Health Clinical Research Services, LLC.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emalex Biosciences Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Syneos Health', 'class': 'OTHER'}, {'name': 'Nuventra, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}