Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-02-20 @ 10:12 PM
Study NCT ID:
NCT02256735
Status:
COMPLETED
Last Update Posted:
2014-10-06
First Post:
2014-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Investigate the Effect of KUC 7483 CL on the QT/QTc Interval of the ECG in Comparison to Placebo and Moxifloxacin in Healthy Male and Female Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003470', 'term': 'Culture Media'}, {'id': 'D000077266', 'term': 'Moxifloxacin'}], 'ancestors': [{'id': 'D019995', 'term': 'Laboratory Chemicals'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'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': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'lastUpdateSubmitDate': '2014-10-02', 'studyFirstSubmitDate': '2014-10-02', 'studyFirstSubmitQcDate': '2014-10-02', 'lastUpdatePostDateStruct': {'date': '2014-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in mean time-matched QTcI', 'timeFrame': 'up to 2 hours following drug administration'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in mean time-matched QTcI', 'timeFrame': 'up to 8 hours following drug administration'}, {'measure': 'Occurrence of uncorrected QT interval', 'timeFrame': 'up to 8 hours following drug administration', 'description': 'QT interval \\<=500 ms, \\> 500 ms'}, {'measure': 'Occurrence of the QTcI interval', 'timeFrame': 'up to 8 hours following drug administration', 'description': 'QTcI interval \\<= 450 ms, \\>450 ms, \\>480 ms or \\>500 ms'}, {'measure': 'Change from baseline of the QTcI interval', 'timeFrame': 'up to 8 hours following drug administration', 'description': 'QTcI interval \\< 30 ms, ≤ 60 ms'}, {'measure': 'Change from baseline in Heart Rate (HR)', 'timeFrame': 'up to 6 hours following drug administration', 'description': 'increase ≥25 % or decrease HR by ≥25 %'}, {'measure': 'Cmax (maximum measured concentration of the analyte in plasma)', 'timeFrame': 'up to 8 hours following drug administration'}, {'measure': 'tmax (time from dosing to the maximum concentration of the analyte in plasma)', 'timeFrame': 'up to 8 hours following drug administration'}, {'measure': 'AUC0-6 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours)', 'timeFrame': 'up to 6 hours following drug administration'}, {'measure': 'AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 8 hours) for moxifloxacin', 'timeFrame': 'up to 8 hours following drug administration'}, {'measure': 'Number of subjects with adverse events', 'timeFrame': 'up to 17 days after last drug administration'}, {'measure': 'Number of subjects with abnormal changes in laboratory parameters', 'timeFrame': 'up to 17 days after last drug administration'}, {'measure': 'Number of subjects with abnormal changes in 12-lead ECG', 'timeFrame': 'up to 17 days after last drug administration'}, {'measure': 'Number of patients with clinically significant changes in vital signs', 'timeFrame': 'up to 17 days after last drug administration', 'description': 'Blood pressure, pulse rate'}, {'measure': 'Assessment of tolerability by investigator on a 4-point scale', 'timeFrame': '17 days after last drug administration'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Study to investigate the effect of Ritobegron CL (KUC 7483 CL) on the QT/QTc interval of the ECG in comparison to placebo and moxifloxacin'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males or females\n* Age 30 to 60 years\n* Body mass index (BMI) within 18.5 to 29.9 kg/m2\n* In accordance with Good Clinical Practice (GCP) and the local legislation all volunteers are to have given their written informed consent prior to admission to the study\n\nExclusion Criteria:\n\n* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance\n* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, clinically relevant electrolyte disturbances\n* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders\n* History of orthostatic hypotension, fainting spells or blackouts\n* Chronic or clinically relevant acute infections\n* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator\n* Intake of drugs with a long half-life (\\> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study\n* Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study\n* Participation in another trial with an investigational drug (within two months prior to administration or during the trial)\n* Smoker (\\> 10 cigarettes or \\> 3 cigars of \\> 3 pipes/day)\n* Inability to refrain from smoking on trial days\n* Drug abuse\n* Blood donation (\\> 100 mL within four weeks prior to administration or during the trial)\n* Any laboratory value outside the reference range if indicative of underlying disease or poor health\n* Excessive physical activities within the last week before the trial or during the trial\n* Hypersensitivity to treatment medication, moxifloxacin and/or related drugs of these classes\n* Previous tendon disease related to quinolone treatment\n* Congenital or documented acquired QT- prolongation, previous history of symptomatic arrhythmias\n* Heart rate at screening of \\> 80 bpm or \\< 45 bpm\n* Any screening ECG value outside of the reference range of clinical relevance including, but not limited to Pulse rate (PR) interval \\> 220 ms, QRS interval \\> 115 ms, QTcB \\> 450 ms, or QT (uncorrected) \\> 470 ms\n\nFor Female Subjects:\n\n* Pregnancy\n* Positive pregnancy test\n* No adequate contraception (adequate contraception e.g. sterilization, Intrauterine pessary (IUP), oral contraceptives)\n* Inability to maintain this adequate contraception during the whole study period\n* Lactation period'}, 'identificationModule': {'nctId': 'NCT02256735', 'briefTitle': 'Study to Investigate the Effect of KUC 7483 CL on the QT/QTc Interval of the ECG in Comparison to Placebo and Moxifloxacin in Healthy Male and Female Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Double-blinded, Randomised, Placebo Controlled, Five-way Crossover Study With One Positive Control (Open-label) (Moxifloxacin) to Assess the Influence of Oral Single Dose KUC 7483 BS (40 mg, 80 mg, 160 mg, 320 mg) on the QT/QTc Interval of the ECG in Healthy Male and Female Volunteers', 'orgStudyIdInfo': {'id': '1207.22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A', 'interventionNames': ['Drug: Treatment A']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B', 'interventionNames': ['Drug: Treatment B']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C', 'interventionNames': ['Drug: Treatment C']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment D', 'interventionNames': ['Drug: Treatment D']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Moxifloxacin', 'interventionNames': ['Drug: Moxifloxacin']}], 'interventions': [{'name': 'Treatment A', 'type': 'DRUG', 'description': 'Ritobegron Cl (KUC 7483 CL) tablets low dose', 'armGroupLabels': ['Treatment A']}, {'name': 'Treatment B', 'type': 'DRUG', 'otherNames': ['Ritobegron Cl (KUC 7483 CL) tablets medium 1 dose'], 'armGroupLabels': ['Treatment B']}, {'name': 'Treatment C', 'type': 'DRUG', 'otherNames': ['Ritobegron Cl (KUC 7483 CL) tablets medium 2 dose'], 'armGroupLabels': ['Treatment C']}, {'name': 'Treatment D', 'type': 'DRUG', 'otherNames': ['Ritobegron Cl (KUC 7483 CL) tablets high dose'], 'armGroupLabels': ['Treatment D']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}, {'name': 'Moxifloxacin', 'type': 'DRUG', 'armGroupLabels': ['Moxifloxacin']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}