Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-01-09 @ 8:50 AM
Study NCT ID:
NCT02161432
Status:
COMPLETED
Last Update Posted:
2016-01-27
First Post:
2014-06-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relative Bioavailability of a BI 187004 Tablet Formulation in Comparison With an Oral Solution and the Influence of Food on the Tablet Formulation in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-26', 'studyFirstSubmitDate': '2014-06-10', 'studyFirstSubmitQcDate': '2014-06-10', 'lastUpdatePostDateStruct': {'date': '2016-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) of BI 187004', 'timeFrame': 'up to 17 days postdose'}, {'measure': 'Cmax (maximum measured concentration of the analyte in plasma) of BI 187004', 'timeFrame': 'up to 17 days postdose'}], 'secondaryOutcomes': [{'measure': 'AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)', 'timeFrame': 'up to 17 days postdose'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To determine the relative bioavailability of an BI 187004 tablet formulation compared to an oral solution of BI 187004 and to assess the influence of food on the bioavailability of the tablet formulation.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Healthy male subjects\n2. Age of 18 to 50 years\n3. Body mass index (BMI) of 18.5 to 29.9 kg/m2\n\nExclusion criteria:\n\n1. Any finding in the medical examination (including BP, pulse rate (PR) or ECG) is deviating from normal and judged as clinically relevant by the investigator\n2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm\n3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance\n4. Any evidence of a concomitant disease judged as clinically relevant by the investigator\n5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n6. Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy and simple hernia repair)\n7. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders'}, 'identificationModule': {'nctId': 'NCT02161432', 'briefTitle': 'Relative Bioavailability of a BI 187004 Tablet Formulation in Comparison With an Oral Solution and the Influence of Food on the Tablet Formulation in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Relative Bioavailability of a BI 187004 Tablet Formulation in Comparison With an Oral Solution and the Influence of Food on the Bioavailability of the Tablet Formulation (a Randomised, Open-label, Single Dose, Three-way Crossover Trial in Healthy Subjects)', 'orgStudyIdInfo': {'id': '1307.3'}, 'secondaryIdInfos': [{'id': '2013-004627-37', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A', 'description': 'single dose of BI 187004 in fasted state', 'interventionNames': ['Drug: BI 187004']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B', 'description': 'single dose of BI 187004', 'interventionNames': ['Drug: BI 187004']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C', 'description': 'single dose of BI 187004 in fed state', 'interventionNames': ['Drug: BI 187004']}], 'interventions': [{'name': 'BI 187004', 'type': 'DRUG', 'description': 'single dose BI 187004 given as tablet in fed state', 'armGroupLabels': ['Treatment C']}, {'name': 'BI 187004', 'type': 'DRUG', 'description': 'single dose BI 187004 given as tablet in fasted state', 'armGroupLabels': ['Treatment A']}, {'name': 'BI 187004', 'type': 'DRUG', 'description': 'single dose BI 187004 given as oral solution', 'armGroupLabels': ['Treatment B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Biberach', 'country': 'Germany', 'facility': '1307.3.1 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 48.33333, 'lon': 8.03333}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}