Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-03-19 @ 6:44 PM
Study NCT ID:
NCT04092712
Status:
COMPLETED
Last Update Posted:
2019-09-25
First Post:
2019-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-24', 'studyFirstSubmitDate': '2019-09-05', 'studyFirstSubmitQcDate': '2019-09-13', 'lastUpdatePostDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mass balance: Calculation of percent of total radioactivity recovered in urine', 'timeFrame': 'From time zero up to 96 hours post-dose following oral administration of [14C]-CTP-543 up to Day 15'}, {'measure': 'Mass balance: Calculation of percent of total radioactivity recovered in feces', 'timeFrame': 'From time zero up to 96 hours post-dose following oral administration of [14C]-CTP-543 up to Day 15'}, {'measure': 'CTP-543 PK: Cmax', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose', 'description': 'Maximum plasma concentration'}, {'measure': 'CTP-543 PK: Tmax', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose', 'description': 'Time for Cmax'}, {'measure': 'CTP-543 PK: t1/2', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose'}, {'measure': 'CTP-543 PK: AUClast', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose', 'description': 'Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration (Clast)'}, {'measure': 'CTP-543 PK: AUCinf', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose', 'description': 'Area under the plasma concentration time profile from time 0 to infinity'}, {'measure': 'CTP-543 PK: CL/F', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose', 'description': 'Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes).'}, {'measure': 'CTP-543 PK: Vz/F', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose', 'description': 'Apparent volume of distribution following oral administration'}, {'measure': 'CTP-543 metabolite PK: Cmax', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose', 'description': 'Maximum plasma concentration'}, {'measure': 'CTP-543 metabolite PK: Tmax', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose', 'description': 'Time for Cmax'}, {'measure': 'CTP-543 metabolite PK: t1/2', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose'}, {'measure': 'CTP-543 metabolite PK: AUC0-last', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose', 'description': 'Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration (Clast)'}, {'measure': 'CTP-543 metabolite PK: AUCinf', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose', 'description': 'Area under the plasma concentration time profile from time 0 to infinity'}, {'measure': 'Total [14C]: urine', 'timeFrame': 'Pre-dose up to 336 hours post-dose', 'description': 'Total radioactivity excreted into the urine from time zero to the time of last measurable concentration following oral administration of \\[14C\\]-CTP-543'}, {'measure': 'Total [14C]: feces', 'timeFrame': 'Pre-dose up to 336 hours post-dose', 'description': 'Total radioactivity excreted into the feces from time zero to the time of last measurable concentration following oral administration of \\[14C\\]-CTP-543'}, {'measure': 'Total radioactivity in whole blood', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose'}, {'measure': 'Total radioactivity in plasma', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'Screening up to Day 15', 'description': 'Number of adverse events, which are any untoward medical occurrence regardless of attribution to study drug in a participant who received study drug'}, {'measure': 'Number of Participants With Clinically Significant Change From Baseline in Heart Rate', 'timeFrame': 'Screening, Pre-dose, 2, 8, 48 hours post-dose', 'description': 'Heart rate measured in beats per minute (bpm)'}, {'measure': 'Number of Participants With Clinically Significant Change From Baseline in Blood Pressure', 'timeFrame': 'Screening, Pre-dose, 2, 8, 48 hours post-dose', 'description': 'Blood pressure measured in millimeters of mercury (mmHg)'}, {'measure': 'Number of Participants With Clinically Significant Change From Baseline in Respiratory Rate', 'timeFrame': 'Screening, Pre-dose, 2, 8, 48 hours post-dose', 'description': 'Respiratory rate measured in breaths per minute'}, {'measure': 'Number of Participants With Clinically Significant Change From Baseline in Temperature', 'timeFrame': 'Screening, Pre-dose, 2, 8, 48 hours post-dose', 'description': 'Temperature measured in Celsius (°C)'}, {'measure': 'Number of Participants With Clinically Significant Change From Baseline in Hematology', 'timeFrame': 'Screening, Check-in, 8, 24 hours postdose'}, {'measure': 'Number of Participants With Clinically Significant Change From Baseline in Serum Chemistry', 'timeFrame': 'Screening, Check-in, 8, 24 hours postdose'}, {'measure': 'Number of Participants With Clinically Significant Change From Baseline in Coagulation', 'timeFrame': 'Screening, Check-in, 8, 24 hours postdose'}, {'measure': 'Number of Participants With Clinically Significant Change From Baseline in Urinalysis', 'timeFrame': 'Screening, Check-in, 8, 24 hours postdose'}, {'measure': 'Number of Participants With Clinically Significant Changes to the Physical Examination', 'timeFrame': 'Screening up to Day 15', 'description': 'Clinically significant changes to the physical examination'}, {'measure': 'Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - P Wave', 'timeFrame': 'Screening, Pre-dose, 48 hours post-dose'}, {'measure': 'Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - QRS Complex', 'timeFrame': 'Screening, Pre-dose, 48 hours post-dose'}, {'measure': 'Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - QT Interval', 'timeFrame': 'Screening, Pre-dose, 48 hours post-dose'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mass Balance', 'Radiolabeled', 'Pharmacokinetics'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This study will assess the absorption, metabolism, excretion, mass balance, safety, and tolerability of a single oral administration of \\[14C\\]-CTP-543 in healthy male subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subjects between the ages of 19 and 55 years, inclusive (healthy is determined by medical evaluation, including medical history, full physical examination, vital signs, electrocardiogram, and clinical laboratory tests)\n* Body Mass Index of 18.0 to 32.0 kg/m2\n* Continuous non smoker who has not used nicotine containing products for at least 3 months prior to dosing and throughout the study\n\nExclusion Criteria:\n\n* Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening\n* Infection with hepatitis B or hepatitis C viruses\n* History of irregular bowel movements\n* History of herpes zoster\n* A positive tuberculosis test at screening or history of incompletely treated or untreated tuberculosis\n* History or presence of alcoholism or drug abuse within the past 2 years prior to dosing\n* Participation in another clinical study within 30 days prior to dosing'}, 'identificationModule': {'nctId': 'NCT04092712', 'briefTitle': 'Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Concert Pharmaceuticals'}, 'officialTitle': 'A Phase 1, Open-label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Oral [14C]-CTP-543 in Healthy Adult Male Subjects', 'orgStudyIdInfo': {'id': 'CP543.1004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Investigational Product', 'description': '\\[14C\\]-CTP-543', 'interventionNames': ['Drug: [14C]-CTP-543']}], 'interventions': [{'name': '[14C]-CTP-543', 'type': 'DRUG', 'description': 'Single dose of radiolabeled CTP-543 (approximately 75 μCi) administered as an oral solution', 'armGroupLabels': ['Investigational Product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68502', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Celerion', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Concert Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Celerion', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}