Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-28 @ 5:11 PM
Study NCT ID:
NCT05841160
Status:
COMPLETED
Last Update Posted:
2023-06-09
First Post:
2023-04-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thorough QT/QTc Study to Evaluate the Effects of Ecopipam (EBS-101) on Cardiac Repolarization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077266', 'term': 'Moxifloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-07', 'studyFirstSubmitDate': '2023-04-10', 'studyFirstSubmitQcDate': '2023-04-21', 'lastUpdatePostDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Evaluate ecopipam's effect on the QTc interval after administration of therapeutic and supratherapeutic doses, compared to placebo as a negative control using C-QTc analysis.", 'timeFrame': 'Up to Day 25', 'description': 'ECGs and PK samples will be collected for up to 96 hours after each dose'}], 'secondaryOutcomes': [{'measure': 'Evaluate the effect of ecopipam at a therapeutic dose on heart rate', 'timeFrame': 'Up to Day 25', 'description': 'ECGs will be collected for up to 48 hours after each dose'}, {'measure': 'Evaluate the effect of ecopipam at a therapeutic dose on PR interval', 'timeFrame': 'Up to Day 25', 'description': 'ECGs will be collected for up to 48 hours after each dose'}, {'measure': 'Evaluate the effect of ecopipam at a therapeutic dose on QRS interval', 'timeFrame': 'Up to Day 25', 'description': 'ECGs will be collected for up to 48 hours after each dose'}, {'measure': 'Evaluate the effect of ecopipam at a therapeutic dose on T-wave morphology', 'timeFrame': 'Up to Day 25', 'description': 'ECGs will be collected for up to 48 hours after each dose'}, {'measure': 'Evaluate the effect of ecopipam at a therapeutic dose on U wave presence', 'timeFrame': 'Up to Day 25', 'description': 'ECGs will be collected for up to 48 hours after each dose'}, {'measure': 'Evaluate the effect of ecopipam at supratherapeutic dose on heart rate', 'timeFrame': 'Up to Day 25', 'description': 'ECGs will be collected for up to 48 hours after each dose'}, {'measure': 'Evaluate the effect of ecopipam at supratherapeutic dose on PR interval', 'timeFrame': 'Up to Day 25', 'description': 'ECGs will be collected for up to 48 hours after each dose'}, {'measure': 'Evaluate the effect of ecopipam at supratherapeutic dose on QRS interval', 'timeFrame': 'Up to Day 25', 'description': 'ECGs will be collected for up to 48 hours after each dose'}, {'measure': 'Evaluate the effect of ecopipam at supratherapeutic dose on T-wave morphology', 'timeFrame': 'Up to Day 25', 'description': 'ECGs will be collected for up to 48 hours after each dose'}, {'measure': 'Evaluate the effect of ecopipam at supratherapeutic dose on U wave presence', 'timeFrame': 'Up to Day 25', 'description': 'ECGs will be collected for up to 48 hours after each dose'}, {'measure': "Evaluate the ECG assay sensitivity to detect a change in the QT interval corrected for heart rate using Fridericia's formula (QTcF interval) using 400 mg moxifloxacin as the positive control", 'timeFrame': 'Up to Day 25', 'description': 'ECGs will be collected for up to 48 hours after each dose'}, {'measure': 'Evaluate the effects of ecopipam on the emergence of arrhythmias', 'timeFrame': 'Up to Day 25', 'description': 'ECGs will be collected for up to 48 hours after each dose'}, {'measure': 'Describe the incidence of treatment-emergent adverse events after a single therapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': 'AEs will be collected throughout the duration of the study'}, {'measure': 'Describe the incidence of treatment-emergent adverse events after a single supratherapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': 'AEs will be collected throughout the duration of the study'}, {'measure': 'Describe the incidence of treatment-emergent adverse events after a single dose of moxifloxacin 400 mg', 'timeFrame': 'Up to Day 33', 'description': 'AEs will be collected throughout the duration of the study'}, {'measure': 'Describe the Cmax of ecopipam after single therapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the Tmax of ecopipam after single therapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the AUClast of ecopipam after single therapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the AUCinf of ecopipam after single therapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the AUCext of ecopipam after single therapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the λz of ecopipam after single therapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the t1/2 of ecopipam after single therapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the Cmax of ecopipam after single supratherapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the Tmax of ecopipam after single supratherapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the AUClast of ecopipam after single supratherapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the AUCinf of ecopipam after single supratherapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the AUCext of ecopipam after single supratherapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the λz of ecopipam after single supratherapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the t1/2 of ecopipam after single supratherapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the Cmax of EBS-101-40853 after single therapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the Tmax of EBS-101-40853 after single therapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the AUClast of EBS-101-40853 after single therapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the AUCinf of EBS-101-40853 after single therapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the AUCext of EBS-101-40853 after single therapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the λz of EBS-101-40853 after single therapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the t1/2 of EBS-101-40853 after single therapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the Cmax of EBS-101-40853 after single supratherapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the Tmax of EBS-101-40853 after single supratherapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the AUClast of EBS-101-40853 after single supratherapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the AUCinf of EBS-101-40853 after single supratherapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the AUCext of EBS-101-40853 after single supratherapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the λz of EBS-101-40853 after single supratherapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the t1/2 of EBS-101-40853 after single supratherapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the Cmax of ecopipam glucuronide after single therapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the Tmax of ecopipam glucuronide after single therapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the AUClast of ecopipam glucuronide after single therapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the AUCinf of ecopipam glucuronide after single therapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the AUCext of ecopipam glucuronide after single therapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the λz of ecopipam glucuronide after single therapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the t1/2 of ecopipam glucuronide after single therapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the Cmax of ecopipam glucuronide after single supratherapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the Tmax of ecopipam glucuronide after single supratherapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the AUClast of ecopipam glucuronide after single supratherapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the AUCinf of ecopipam glucuronide after single supratherapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the AUCext of ecopipam glucuronide after single supratherapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the λz of ecopipam glucuronide after single supratherapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the t1/2 of ecopipam glucuronide after single supratherapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the Cmax of EBS-101-40853 glucuronide after single therapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the Tmax of EBS-101-40853 glucuronide after single therapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the AUClast of EBS-101-40853 glucuronide after single therapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the AUCinf of EBS-101-40853 glucuronide after single therapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the AUCext of EBS-101-40853 glucuronide after single therapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the λz of EBS-101-40853 glucuronide after single therapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the t1/2 of EBS-101-40853 glucuronide after single therapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the Cmax of EBS-101-40853 glucuronide after single supratherapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the Tmax of EBS-101-40853 glucuronide after single supratherapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the AUClast of EBS-101-40853 glucuronide after single supratherapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the AUCinf of EBS-101-40853 glucuronide after single supratherapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the AUCext of EBS-101-40853 glucuronide after single supratherapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the λz of EBS-101-40853 glucuronide after single supratherapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the t1/2 of EBS-101-40853 glucuronide after single supratherapeutic dose of ecopipam', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the Cmax of moxifloxacin after a single dose of moxifloxacin 400 mg', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the Tmax of moxifloxacin after a single dose of moxifloxacin 400 mg', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the AUClast of moxifloxacin after a single dose of moxifloxacin 400 mg', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the AUCinf of moxifloxacin after a single dose of moxifloxacin 400 mg', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the AUCext of moxifloxacin after a single dose of moxifloxacin 400 mg', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the λz of moxifloxacin after a single dose of moxifloxacin 400 mg', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}, {'measure': 'Describe the t1/2 of moxifloxacin after a single dose of moxifloxacin 400 mg', 'timeFrame': 'Up to Day 33', 'description': '17 blood samples will be collected at the indicated timepoints for pharmacokinetic analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['QT/QTc']}, 'descriptionModule': {'briefSummary': 'THOROUGH QT/QTc STUDY TO EVALUATE THE EFFECTS OF ECOPIPAM (EBS-101) ON CARDIAC REPOLARIZATION', 'detailedDescription': 'This is a single-center, randomized, partially double-blind (open-label moxifloxacin), placebo- and positive-controlled, 4-way crossover study in healthy subjects. Following a 28 day screening period, eligible subjects will enter the clinical research unit (CRU) on Day -1. A total of 32 subjects will be randomized in a 1:1:1:1 ratio to 1 of 4 treatment sequences (8 subjects per treatment sequence). Subjects will receive the assigned study drug as a single oral dose in the morning on Day 1 of each treatment period (Day 1 \\[Period 1\\], Day 8 \\[Period 2\\], Day 15 \\[Period 3\\], and Day 22 \\[Period 4\\]) after an overnight fast. Subjects will have serially matched blood samples (for determination of plasma concentrations) and 12-lead ECGs collected at predose and up to 48 hours after each dose for C QTc analysis. Subjects will be discharged from the CRU 96 hours after the last dose of the study drug (Day 26). A follow-up telephone call will occur 5 ±2 days after discharge (Day 31 ±2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female of nonchildbearing potential\n* 18 to 55 years of age\n* BMI of 18 to 30 kg/m2, and weight of at least 50 kg for males and 45 kg for females.\n* Subject considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and PE findings.\n* Male subjects with female partners of childbearing potential must agree to use a double-barrier method of contraception during the study and agree to continue the use of male contraception for at least 90 days after the last dose of study drug.\n* Male subjects must be willing to refrain from donating sperm during study participation and for 90 days after the last dose of study drug.\n* The subject is able to provide written informed consent and agrees to comply with all protocol requirements.\n\nExclusion Criteria:\n\n* Female subjects of childbearing potential or who are currently pregnant or lactating\n* Subjects with a history of significant medical illness\n* Clinically significant abnormalities on screening tests/exams\n* History of or serious risk of committing suicide\n* Donation of plasma within 7 days prior to dosing\n* Donation of significant loss of blood within 30 days prior to dosing\n* Major surgery within 3 months or minor surgery within 1 month prior to CRU admission\n* Use of prohibited prescription, over-the-counter medications or natural health products\n* Alcohol-based products within 24 hours prior to check-in on Day -1\n* Vaccinations within 72 hours prior to check-in on Day -1\n* Subjects with a history of any clinically significant ECG or vital sign abnormalities or presence of any clinically significant ECG or vital sign abnormalities or changes at screening or on Day -1\n* Positive test result for drugs of abuse, alcohol, or cotinine\n* Use of nicotine or nicotine-containing products within 90 days before the first dose of study drug.\n* Subjects with a history of excessive alcohol intake or abuse or drug addiction within the last year\n* Subjects with a history of allergy, allergic skin rash, asthma, or an intolerance, sensitivity, or photosensitivity to moxifloxacin or ecopipam\n* Subjects who have participated in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dose or administration of a biological product in the context of a clinical research study within 90 days prior to the first dose\n* Subjects with prior exposure to ecopipam\n* Any subject who, in the opinion of the investigator, is not a suitable candidate for the study.'}, 'identificationModule': {'nctId': 'NCT05841160', 'briefTitle': 'Thorough QT/QTc Study to Evaluate the Effects of Ecopipam (EBS-101) on Cardiac Repolarization', 'organization': {'class': 'INDUSTRY', 'fullName': 'Emalex Biosciences Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo- and Positive Controlled, Crossover, Thorough QT/QTc Study to Evaluate the Effects of a Therapeutic and Supratherapeutic Dose of Ecopipam (EBS-101) on Cardiac Repolarization in Healthy Subjects', 'orgStudyIdInfo': {'id': 'EBS-101-HV-105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '200 mg ecopipam HCL', 'description': 'Single 200 mg dose of ecopipam HCL given as 2 x 100 mg ecopipam HCL oral tablets and 4 placebo oral tablets', 'interventionNames': ['Drug: Ecopipam Hydrochloride', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '600 mg ecopipam HCL', 'description': 'Single 600 mg dose of ecopipam HCL given as 6 x 100 mg ecopipam HCL oral tablets', 'interventionNames': ['Drug: Ecopipam Hydrochloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': '400 mg moxifloxacin', 'description': 'Single 400 mg dose of moxifloxacin given as 1 x 400 mg oral tablet', 'interventionNames': ['Drug: Moxifloxacin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Single oral dose of 6 x placebo tablets', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ecopipam Hydrochloride', 'type': 'DRUG', 'description': 'oral tablets', 'armGroupLabels': ['200 mg ecopipam HCL', '600 mg ecopipam HCL']}, {'name': 'Moxifloxacin', 'type': 'DRUG', 'description': 'oral tablet', 'armGroupLabels': ['400 mg moxifloxacin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral tablet', 'armGroupLabels': ['200 mg ecopipam HCL', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'PPD Austin Phase 1 Clinical Research Unit', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emalex Biosciences Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'PPD Development, LP', 'class': 'INDUSTRY'}, {'name': 'Clario', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}