Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT04764851
Status:
TERMINATED
Last Update Posted:
2021-05-24
First Post:
2021-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'A number of subjects withdrew consent leaving the study without adequate power to achieve its primary end points.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-20', 'studyFirstSubmitDate': '2021-01-18', 'studyFirstSubmitQcDate': '2021-02-18', 'lastUpdatePostDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax of dextromethorphan (and its dextrorphan metabolite) in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'Cmax of dextromethorphan (and its dextrorphan metabolite) in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': "Cmax of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam", 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': "Cmax of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam", 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': "Cmax of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam", 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': "Cmax oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam", 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'Cmax of dabigatran in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'Cmax of dabigatran in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'Cmax of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'Cmax of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'Cmax of rosuvastatin in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'Cmax of rosuvastatin in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': "Cmax of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam", 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': "Cmax of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam", 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'AUCinf of dextromethorphan (and its dextrorphan metabolite) in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'AUCinf of dextromethorphan (and its dextrorphan metabolite) in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': "AUCinf of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam", 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': "AUCinf of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam", 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': "AUCinf of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam", 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': "AUCinf of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam", 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'AUCinf of dabigatran in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'AUCinf of dabigatran in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'AUCinf of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'AUCinf of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic'}, {'measure': 'AUCinf of rosuvastatin in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic'}, {'measure': 'AUCinf of rosuvastatin in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic'}, {'measure': "AUCinf of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam", 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic'}, {'measure': "AUCinf of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam", 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic'}, {'measure': 'AUClast of dextromethorphan (and its dextrorphan metabolite) in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic'}, {'measure': 'AUClast of dextromethorphan (and its dextrorphan metabolite) in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic'}, {'measure': "AUClast of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam", 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic'}, {'measure': "AUClast of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam", 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic'}, {'measure': "AUClast of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam", 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic'}, {'measure': "AUClast of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam", 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic'}, {'measure': 'AUClast of dabigatran in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic'}, {'measure': 'AUClast of dabigatran in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic'}, {'measure': 'AUClast of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic'}, {'measure': 'AUClast of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic'}, {'measure': 'AUClast of rosuvastatin in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic'}, {'measure': 'AUClast of rosuvastatin in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic'}, {'measure': "AUClast of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam", 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic'}, {'measure': "AUClast of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam", 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic'}], 'secondaryOutcomes': [{'measure': 'Cmax of bupropion (and its 4-hydroxybupropion metabolite) in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'Cmax of bupropion (and its 4-hydroxybupropion metabolite) in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'Cmax of caffeine (and its metabolite paraxanthine) in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'Cmax of caffeine (and its metabolite paraxanthine) in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': "Cmax omeprazole (and its 5'-hydroxy omeprazole metabolite) in the presence of ecopipam", 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': "Cmax omeprazole (and its 5'-hydroxy omeprazole metabolite) in the absence of ecopipam", 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'AUCinf of bupropion (and its 4-hydroxybupropion metabolite) in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'AUCinf of bupropion (and its 4-hydroxybupropion metabolite) in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'AUCinf of caffeine (and its metabolite paraxanthine) in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'AUCinf of caffeine (and its metabolite paraxanthine) in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': "AUCinf of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the presence of ecopipam", 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': "AUCinf of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the absence of ecopipam", 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'AUClast of bupropion (and its 4-hydroxybupropion metabolite) in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'AUClast of bupropion (and its 4-hydroxybupropion metabolite) in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'AUClast of caffeine (and its metabolite paraxanthine) in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'AUClast of caffeine (and its metabolite paraxanthine) in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': "AUClast of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the presence of ecopipam", 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': "AUClast of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the absence of ecopipam", 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'CL/F for dextromethorphan in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'CL/F for dextromethorphan in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'CL/F for IV midazolam in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'CL/F for IV midazolam in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'CL/F for oral midazolam in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'CL/F for oral midazolam in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'CL/F for dabigatran in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'CL/F for dabigatran in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'CL/F for pitavastatin in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'CL/F for pitavastatin in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'CL/F for rosuvastatin in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'CL/F for rosuvastatin in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'CL/F for atorvastatin in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'CL/F for atorvastatin in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'CL/F for bupropion in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'CL/F for bupropion in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'CL/F for caffeine in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'CL/F for caffeine in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'CL/F for omeprazole in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'CL/F for omeprazole in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'V/F for dextromethorphan in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'V/F for dextromethorphan in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'V/F for IV midazolam in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'V/F for IV midazolam in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'V/F for oral midazolam in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'V/F for oral midazolam in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'V/F for dabigatran in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'V/F for dabigatran in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'V/F for pitavastatin in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'V/F for pitavastatin in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'V/F for rosuvastatin in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'V/F for rosuvastatin in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'V/F for atorvastatin in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'V/F for atorvastatin in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'V/F for bupropion in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'V/F for bupropion in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'V/F for caffeine in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'V/F for caffeine in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'V/F for omeprazole in the presence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'V/F for omeprazole in the absence of ecopipam', 'timeFrame': 'Up to Day 18', 'description': 'Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis'}, {'measure': 'Total concentration of bilirubin in the presence of ecopipam', 'timeFrame': 'Up to Day 13', 'description': 'Bilirubin sampling will occur on Day 1 and Day 13'}, {'measure': 'Total concentration of bilirubin in the absence of ecopipam', 'timeFrame': 'Up to Day 13', 'description': 'Bilirubin sampling will occur on Day 1 and Day 13'}, {'measure': 'Unconjugated concentration of bilirubin in the presence of ecopipam', 'timeFrame': 'Up to Day 13', 'description': 'Bilirubin sampling will occur on Day 1 and Day 13'}, {'measure': 'Unconjugated concentration of bilirubin in the absence of ecopipam', 'timeFrame': 'Up to Day 13', 'description': 'Bilirubin sampling will occur on Day 1 and Day 13'}, {'measure': 'Safety and tolerability as demonstrated by MOAA/S', 'timeFrame': 'Up to Day 55', '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 55', '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 55', 'description': 'Safety and tolerability measures will be recorded at the indicated timepoints.'}, {'measure': 'AEs with relatedness associated with dextromethorphan', 'timeFrame': 'Up to Day 55', 'description': 'Subjects will be continually monitored for adverse events'}, {'measure': 'AEs with relatedness associated with IV midazolam', 'timeFrame': 'Up to Day 55', 'description': 'Subjects will be continually monitored for adverse events'}, {'measure': 'AEs with relatedness associated with oral midazolam', 'timeFrame': 'Up to Day 55', 'description': 'Subjects will be continually monitored for adverse events'}, {'measure': 'AEs with relatedness associated with dabigatran', 'timeFrame': 'Up to Day 55', 'description': 'Subjects will be continually monitored for adverse events'}, {'measure': 'AEs with relatedness associated with pitavastatin', 'timeFrame': 'Up to Day 55', 'description': 'Subjects will be continually monitored for adverse events'}, {'measure': 'AEs with relatedness associated with rosuvastatin', 'timeFrame': 'Up to Day 55', 'description': 'Subjects will be continually monitored for adverse events'}, {'measure': 'AEs with relatedness associated with atorvastatin', 'timeFrame': 'Up to Day 55', 'description': 'Subjects will be continually monitored for adverse events'}, {'measure': 'AEs with relatedness associated with bupropion', 'timeFrame': 'Up to Day 55', 'description': 'Subjects will be continually monitored for adverse events'}, {'measure': 'AEs with relatedness associated with caffeine', 'timeFrame': 'Up to Day 55', 'description': 'Subjects will be continually monitored for adverse events'}, {'measure': 'AEs with relatedness associated with omeprazole', 'timeFrame': 'Up to Day 55', 'description': 'Subjects will be continually monitored for adverse events'}, {'measure': 'AEs with relatedness associated with ecopipam', 'timeFrame': 'Up to Day 55', 'description': 'Subjects will be continually monitored for adverse events'}, {'measure': 'Absolute values of white blood cell (WBC) count (K/Ul)', 'timeFrame': 'Up to Day 25', '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': 'Blood samples will be collected for the assessment of hematology parameters.', 'description': 'Up to Day 25'}, {'measure': 'Absolute values of platelets (K/uL)', 'timeFrame': 'Up to Day 25', 'description': 'Blood samples will be collected for the assessment of hematology parameters.'}, {'measure': 'Absolute values of hematocrit (%)', 'timeFrame': 'Up to Day 25', 'description': 'Blood samples will be collected for the assessment of hematology parameters.'}, {'measure': 'Absolute values of hemoglobin (g/dL)', 'timeFrame': 'Up to Day 25', '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 25', '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 25', '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 25', '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 25', '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) (U/L)', 'timeFrame': 'Up to Day 25', 'description': 'Blood samples will be collected for the assessment of clinical chemistry parameters.'}, {'measure': 'Absolute values of urine specific gravity', 'timeFrame': 'Up to Day 25', 'description': 'Urine samples will be collected for the assessment of urine parameters.'}, {'measure': 'Absolute values of urine pH', 'timeFrame': 'Up to Day 25', 'description': 'Urine samples will be collected for the assessment of urine parameters.'}, {'measure': 'Absolute values of urine glucose', 'timeFrame': 'Up to Day 25', 'description': 'Urine samples will be collected for the assessment of urine parameters.'}, {'measure': 'Absolute values of urine protein', 'timeFrame': 'Up to Day 25', 'description': 'Urine samples will be collected for the assessment of urine parameters.'}, {'measure': 'Absolute values of urine blood', 'timeFrame': 'Up to Day 25', 'description': 'Urine samples will be collected for the assessment of urine parameters.'}, {'measure': 'Absolute values of urine ketones', 'timeFrame': 'Up to Day 25', '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 25', 'description': 'Urine samples will be collected for the assessment of urine parameters.'}, {'measure': 'Absolute values of urine leukocytes by dipstick', 'timeFrame': 'Up to Day 25', '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 25', '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 25', '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 25', '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 25', '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 25', '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 25', '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 25', '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 25', '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 25', '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 25', '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 25', '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 25', '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 25', '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 25', '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 25', '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 25', '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 25', '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 25', 'description': 'Urine samples will be collected for the assessment of urine 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 25', '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 25', '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 25', '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 25', 'description': 'Temperature will be assessed as part of vital signs.'}, {'measure': 'Absolute values of heart rate (beats/minute)', 'timeFrame': 'Up to Day 25', '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 25', 'description': 'Heart rate will be assessed as part of vital signs.'}, {'measure': 'Absolute values of respiratory rate (breaths/minute)', 'timeFrame': 'Up to Day 25', '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 25', '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 25', '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 25', 'description': 'Blood pressure will be assessed as part of vital signs.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Drug-Interactions']}, 'descriptionModule': {'briefSummary': 'This is a single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI) study in healthy subjects.', 'detailedDescription': 'Following a screening period of up to 28 days, subjects will be admitted to the clinical research unit into one of three cohorts. On the morning of Day 1, subjects in cohorts 1, 2, and 3 will receive fasted doses of probe substrate(s) per assigned cohort. On Day 5, Cohort 2 only will receive a second fasted dose of probe substrates. Subjects in cohorts 1, 2, and 3 will receive the final fasted dose of probe substrate(s) on Day 13. Fasted ecopipam administration will begin on Day 5 and will continue through Day 17 at \\~2mg/kg for all cohorts. Ecopipam doses will be tapered starting on Day 18 by 25 mg/day increments until subjects are off drug, with final discharge occurring 24 hours after the ecopipam HCl dose has been reduced to 25 mg (Day 21, 23, or 25).'}, '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 for males or ≥45 kg for females\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* Positive pregnancy test\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* Undergoing abrupt discontinuation of alcohol or sedatives\n* Not suitable for study in the opinion of the Principal Investigator'}, 'identificationModule': {'nctId': 'NCT04764851', 'briefTitle': 'Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates', 'organization': {'class': 'INDUSTRY', 'fullName': 'Emalex Biosciences Inc.'}, 'officialTitle': 'A Phase 1, Open-Label, Fixed Sequence Drug-Drug Interaction Study to Evaluate the Effects of Repeat Doses of Ecopipam on the Pharmacokinetics of Multiple Substrates for Drug Metabolism and Transport in Healthy Subjects', 'orgStudyIdInfo': {'id': 'EBS-101-HV-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cohort 1', 'description': 'ecopipam HCl oral tablets of 12.5, 50, 75, and 100 mg daily for up to 20 days\n\nCohort 1 Probe Cocktail given on 2 separate days:\n\n* midazolam: 1 µg infused IV\n* caffeine: 200 mg oral tablet\n* omeprazole: two 20 mg oral tablets\n* dextromethorphan: 1.6mL (containing \\~10 mg) oral solution', 'interventionNames': ['Drug: ecopipam HCl ~2mg/kg/day', 'Combination Product: Cohort 1 Probe Cocktail']}, {'type': 'OTHER', 'label': 'Cohort 2', 'description': 'ecopipam HCl oral tablets of 12.5, 50, 75, and 100 mg daily for up to 20 days\n\nCohort 2 Probe Cocktail given on 3 separate days:\n\n* midazolam: 10 µg/mL given as 1mL oral solution.\n* dabigatran: 375 µg/mL and pitavastatin: 10 µg/mL given as 1mL oral solution\n* rosuvastatin: 25 µg/mL and atorvastatin: 50 µg/mL given as 2mL oral solution', 'interventionNames': ['Drug: ecopipam HCl ~2mg/kg/day', 'Combination Product: Cohort 2 Probe Cocktail']}, {'type': 'OTHER', 'label': 'Cohort 3', 'description': 'ecopipam HCl oral tablets of 12.5, 50, 75, and 100 mg daily for up to 20 days\n\nCohort 3 Probe Cocktail given on 2 separate days:\n\n\\- bupropion: 100mg oral tablet', 'interventionNames': ['Drug: ecopipam HCl ~2mg/kg/day', 'Combination Product: Cohort 3 Probe Cocktail']}], 'interventions': [{'name': 'ecopipam HCl ~2mg/kg/day', 'type': 'DRUG', 'description': 'oral tablet', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3']}, {'name': 'Cohort 1 Probe Cocktail', 'type': 'COMBINATION_PRODUCT', 'description': 'dextromethorphan, caffeine, omeprazole, and midazolam', 'armGroupLabels': ['Cohort 1']}, {'name': 'Cohort 2 Probe Cocktail', 'type': 'COMBINATION_PRODUCT', 'description': 'dabigatran, pitavastatin, rosuvastatin, atorvastatin, midazolam', 'armGroupLabels': ['Cohort 2']}, {'name': 'Cohort 3 Probe Cocktail', 'type': 'COMBINATION_PRODUCT', 'description': 'bupropion', 'armGroupLabels': ['Cohort 3']}]}, '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}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emalex Biosciences Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Syneos Health', 'class': 'OTHER'}, {'name': 'Nuventra, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}