Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2026-01-19 @ 10:58 PM
Study NCT ID:
NCT02241759
Status:
COMPLETED
Last Update Posted:
2015-02-16
First Post:
2014-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Electrocardiographic Effects of TA-8995
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000597751', 'term': 'TA-8995'}, {'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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-12', 'studyFirstSubmitDate': '2014-08-20', 'studyFirstSubmitQcDate': '2014-09-12', 'lastUpdatePostDateStruct': {'date': '2015-02-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in QT interval corrected for heart rate (QTc) for TA-8995 versus placebo', 'timeFrame': '4 days'}], 'secondaryOutcomes': [{'measure': 'Relationship between plasma levels of TA-8995 and the QTcF effect', 'timeFrame': '4 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dyslipidaemia']}, 'descriptionModule': {'briefSummary': 'A study in healthy males and females to see if a high single dose of TA-8995 has an effect on the ECG QTcF interval.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or females of non-child bearing potential\n\nExclusion Criteria:\n\n* Receiving any other drug therapy\n* Clinically significant medical history\n* Abnormal ECGs or vital signs'}, 'identificationModule': {'nctId': 'NCT02241759', 'briefTitle': 'Study of the Electrocardiographic Effects of TA-8995', 'organization': {'class': 'INDUSTRY', 'fullName': 'Xention Ltd'}, 'officialTitle': 'A Phase I, Single-Centre, Randomised, Placebo and Positive- Controlled, Parallel-Group Study of the Electrocardiographic Effects of TA-8995 in Healthy Male and Female Subjects', 'orgStudyIdInfo': {'id': 'TA-8995-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TA-8995', 'description': 'Single oral dose of 150mg TA-8995', 'interventionNames': ['Drug: TA-8995']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Single oral dose of placebo to TA-8995', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Moxifloxacin', 'description': 'Single open-label oral dose of 400mg moxifloxacin', 'interventionNames': ['Drug: Moxifloxacin']}], 'interventions': [{'name': 'TA-8995', 'type': 'DRUG', 'armGroupLabels': ['TA-8995']}, {'name': 'Moxifloxacin', 'type': 'DRUG', 'armGroupLabels': ['Moxifloxacin']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS2 9LH', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Covance Clinical Research Unit Ltd', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'overallOfficials': [{'name': 'Ashley Brooks', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Covance'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xention Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}