Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-28 @ 11:42 AM
Study NCT ID:
NCT02265666
Status:
COMPLETED
Last Update Posted:
2014-10-16
First Post:
2014-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relative Bioavailability, Safety and Tolerability of Two Tablet Formulations of BIIL 284 BS
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': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'lastUpdateSubmitDate': '2014-10-15', 'studyFirstSubmitDate': '2014-10-15', 'studyFirstSubmitQcDate': '2014-10-15', 'lastUpdatePostDateStruct': {'date': '2014-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)', 'timeFrame': 'up to 24 hours after drug administration'}, {'measure': 'Cmax (Maximum measured concentration of the analyte in plasma)', 'timeFrame': 'up to 24 hours after drug administration'}], 'secondaryOutcomes': [{'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)', 'timeFrame': 'up to 24 hours after drug administration'}, {'measure': 'tmax (Time from dosing to the maximum concentration of the analyte in plasma)', 'timeFrame': 'up to 24 hours after drug administration'}, {'measure': 'Terminal rate constant in plasma', 'timeFrame': 'up to 24 hours after drug administration'}, {'measure': 't½ (Terminal half-life of the analyte in plasma)', 'timeFrame': 'up to 24 hours after drug administration'}, {'measure': 'MRTtot (total mean residence time)', 'timeFrame': 'up to 24 hours after drug administration'}, {'measure': 'CL/F (Apparent clearance of the analyte in plasma following extravascular administration)', 'timeFrame': 'up to 24 hours after drug administration'}, {'measure': 'Vz/F (Apparent volume of distribution of the analyte during the terminal phase)', 'timeFrame': 'up to 24 hours after drug administration'}, {'measure': 'Number of subjects with adverse events', 'timeFrame': 'up to 8 days after last drug administration'}, {'measure': 'Number of subjects with clinically significant findings in vital functions', 'timeFrame': 'up to 8 days after last drug administration', 'description': 'blood pressure, pulse rate, ECG'}, {'measure': 'Number of subjects with clinically significant findings in laboratory tests', 'timeFrame': 'up to 8 days after last drug administration'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective of the present study is to investigate the relative bioavailability of BIIL 284 BS Tablet FF in comparison to the tablet C at a dose of 5 mg after a standard breakfast in healthy male volunteers'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All participants are healthy males\n* Age range from 21 to 50 years\n* Broca-Index: within +- 20% of normal weight\n* In accordance with Good Clinical Practice (GCP) and local legislation each volunteer is supposed to give 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\n* Diseases of the central nervous system (such as epilepsy) or with psychiatric 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 a drug with a long half-life (\\> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrollment in the study\n* Use of any drugs which might influence the results of the trial (\\<= one week prior to administration or during the trial)\n* Participation in another trial with an investigational drug (\\<= two months prior to administration or during the trial)\n* Smoker (\\> 10 cigarettes or 3 cigars or 3 pipes/day)\n* Inability to refrain from smoking on study days\n* Alcohol abuse (\\> 60g/day)\n* Drug abuse\n* Blood donation (\\>= 100 mL within four weeks prior to administration or during the trial)\n* Excessive physical activities (within the last week before the study )\n* Any laboratory value outside the reference range of clinical relevance'}, 'identificationModule': {'nctId': 'NCT02265666', 'briefTitle': 'Relative Bioavailability, Safety and Tolerability of Two Tablet Formulations of BIIL 284 BS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Randomised, Open-label, Two-way Crossover Study in Male Healthy Volunteers to Investigate the Relative Bioavailability of BIIL 284 BS 5 mg Tablet FF in Comparison to Tablet C After Ingestion of a Standardised Meal', 'orgStudyIdInfo': {'id': '543.31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIIL 284 BS Tablet FF', 'interventionNames': ['Drug: BIIL 284 BS Tablet FF', 'Other: standard breakfast']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BIIL 284 BS tablet C', 'interventionNames': ['Drug: BIIL 284 BS tablet C', 'Other: standard breakfast']}], 'interventions': [{'name': 'BIIL 284 BS Tablet FF', 'type': 'DRUG', 'armGroupLabels': ['BIIL 284 BS Tablet FF']}, {'name': 'BIIL 284 BS tablet C', 'type': 'DRUG', 'armGroupLabels': ['BIIL 284 BS tablet C']}, {'name': 'standard breakfast', 'type': 'OTHER', 'armGroupLabels': ['BIIL 284 BS Tablet FF', 'BIIL 284 BS tablet C']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}