Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT05192369
Status:
COMPLETED
Last Update Posted:
2022-03-04
First Post:
2022-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Randomized Study to Evaluate the Effects of CTP-543 on the QT/QTc Intervals in Health Volunteers
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-16', 'studyFirstSubmitDate': '2022-01-05', 'studyFirstSubmitQcDate': '2022-01-05', 'lastUpdatePostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TQT Analysis', 'timeFrame': 'Before dosing (pre-dose) through 24 hours post-dose on Day 1, Day 4, Day 7, and Day 10', 'description': "Analysis of the change from pre-dose-averaged baseline Fridericia's corrected QT interval (QTcF) at each post-dose timepoint"}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CTP-543'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This is a four-arm, randomized, crossover, placebo and active controlled study to evaluate of the effect of therapeutic and supratherapeutic doses of CTP-543 on the QT/QTc intervals in healthy volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy, non-smoking, adult males or females aged 18-60\n* Body mass index of 18 to 32 mg/m2 at Screening\n* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or Electrocardiograms (ECGs)\n* If of reproductive age, willing and able to use a medically highly effective form of birth control 30 days prior to first dose, during the study and for 30 days following last dose of study medication\n* Understands the study procedures in the informed consent form and be willing and able to comply with the protocol\n\nExclusion Criteria:\n\n* History or presence of clinically significant medical or psychiatric condition or disease\n* History of any illness that might confound the results of the study or poses an additional risk to the subject by their participation in the study\n* History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing\n* History of prolonged QT syndrome or a Corrected QT-interval (QTc) with Fridericia's correction (QTcF) \\> 450 msec for males or QTcF \\> 470 msec for females obtained at Screening visit or prior to the first dosing\n* Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug\n* Positive results at Screening for human immunodeficiency virus, hepatitis B surface antigen or hepatitis C virus\n* A positive test or history of incompletely treated or untreated tuberculosis"}, 'identificationModule': {'nctId': 'NCT05192369', 'briefTitle': 'A Randomized Study to Evaluate the Effects of CTP-543 on the QT/QTc Intervals in Health Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Concert Pharmaceuticals'}, 'officialTitle': 'A Four-Arm, Randomized, Crossover, Placebo and Active Controlled Study for the Evaluation of the Effect of Therapeutic and Supratherapeutic Doses of CTP-543 on the QT/QTc Intervals in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'CP543.1010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A: Therapeutic Dose', 'description': 'Single oral dose of 12mg CTP-543', 'interventionNames': ['Drug: CTP-543']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B: Supratherapeutic Dose', 'description': 'Single oral dose of 48mg CTP-543', 'interventionNames': ['Drug: CTP-543']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment D: Placebo', 'description': 'Single oral dose of 1 Placebo tablet', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment C: Positive Control', 'description': 'Single oral dose of 400mg Moxifloxacin', 'interventionNames': ['Drug: Moxifloxacin']}], 'interventions': [{'name': 'CTP-543', 'type': 'DRUG', 'description': 'CTP-543 12 mg (1 x 12 mg tablet), dosed with water', 'armGroupLabels': ['Treatment A: Therapeutic Dose']}, {'name': 'CTP-543', 'type': 'DRUG', 'description': 'CTP-543 48 mg (4 x 12 mg tablet) dosed with water', 'armGroupLabels': ['Treatment B: Supratherapeutic Dose']}, {'name': 'Moxifloxacin', 'type': 'DRUG', 'description': 'Moxifloxacin (1 x 400 mg tablet) dosed with water', 'armGroupLabels': ['Treatment C: Positive Control']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo (1 tablet) dosed with water', 'armGroupLabels': ['Treatment D: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33014', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Pharmacology of Miami, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Concert Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}