Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 11:07 PM
Study NCT ID:
NCT02183467
Status:
COMPLETED
Last Update Posted:
2014-07-08
First Post:
2014-07-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of BI 1356 as Single Dose on the QT Interval in Healthy Female and Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069476', 'term': 'Linagliptin'}, {'id': 'D000077266', 'term': 'Moxifloxacin'}], 'ancestors': [{'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'lastUpdateSubmitDate': '2014-07-04', 'studyFirstSubmitDate': '2014-07-04', 'studyFirstSubmitQcDate': '2014-07-04', 'lastUpdatePostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline of the QTcI interval (individually heart rate-corrected QT interval length)', 'timeFrame': 'Pre-dose and 1 to 4 hours following administration'}], 'secondaryOutcomes': [{'measure': 'Mean of the QTcI change from baseline of all electrocardiograms (ECGs) taken from 1 hour to 24 hours after dosing', 'timeFrame': 'up to 24 hours following administration'}, {'measure': 'Change from mean baseline of the QTcI at any point in time between 1 and 24 hours after dosing', 'timeFrame': 'up to 24 hours following administration'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Assessment of the effect of BI 1356 or Placebo on prolongation of the QT interval'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males and females, 21 to 50 years of age\n* Body mass index (BMI) ranging from 18.5 to 29.9 kg/m2\n* Signed written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation\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\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 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 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 (≤ 60 days prior to administration or during the trial)\n* Heavy smoker (\\> 10 cigarettes or \\> 3 cigars of \\> 3 pipes/day)\n* Inability to refrain from smoking on trial days\n* Alcohol abuse (\\> 60 g/day)\n* Drug abuse\n* Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)\n* Any deviation of a laboratory value that is considered to be of clinical relevance\n* Excessive physical activities within the last week before the trial or during the trial\n* Hypersensitivity to Moxifloxacin or related drugs of these classes\n* Supine blood pressure at screening of systolic \\< 100 mmHg and diastolic \\< 60 mmHg\n* Heart rate at screening of \\> 80 bpm or \\< 40 bpm\n* Any screening ECG value outside of the reference range of clinical relevance including, but not limited to PR interval \\> 220 ms, QRS interval \\> 115 ms, QTcB or QTcF \\> 450 ms, or QT (uncorrected) \\> 470 ms\n* Subjects involved in passenger transport or operation of dangerous machines\n\nFor Female subjects:\n\n* Pregnancy or positive pregnancy test, or planning to become pregnant during the study or within 1 month of study completion Pregnancy\n* No adequate contraception during the study and until 1 month of study completion, i.e. implants, injectables, combined oral contraceptives, IUD \\[intrauterine device\\], sexual abstinence (for at least 1 month prior to enrolment), vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (incl. hysterectomy). Females, who have not a vasectomised partner, are not sexually abstinent or surgically sterile will be asked to additionally use barrier contraception methods (e.g. condom, diaphragm with spermicide)\n* Lactation period'}, 'identificationModule': {'nctId': 'NCT02183467', 'briefTitle': 'Effect of BI 1356 as Single Dose on the QT Interval in Healthy Female and Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Assessment of the Effect of 5 mg and 100 mg of BI 1356 as Single Dose on the QT Interval in Healthy Female and Male Subjects. A Randomised, Placebo Controlled, Double-blind, Four-way Crossover Study With Moxifloxacin as Positive Control', 'orgStudyIdInfo': {'id': '1218.32'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI 1356, low dose', 'interventionNames': ['Drug: BI 1356, low dose']}, {'type': 'EXPERIMENTAL', 'label': 'BI 1356, high dose', 'interventionNames': ['Drug: BI 1356, high dose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Moxifloxacin', 'interventionNames': ['Drug: Moxifloxacin']}], 'interventions': [{'name': 'BI 1356, low dose', 'type': 'DRUG', 'armGroupLabels': ['BI 1356, low dose']}, {'name': 'BI 1356, high dose', 'type': 'DRUG', 'armGroupLabels': ['BI 1356, high dose']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}, {'name': 'Moxifloxacin', 'type': 'DRUG', 'otherNames': ['Avalox®'], 'armGroupLabels': ['Moxifloxacin']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}