Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-02-25 @ 6:35 PM
Study NCT ID:
NCT02265302
Status:
COMPLETED
Last Update Posted:
2014-10-15
First Post:
2014-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, Biological Effects and Pharmacokinetics of BIIL 284 BS in Healthy Males
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C424425', 'term': 'amelubant'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'lastUpdateSubmitDate': '2014-10-14', 'studyFirstSubmitDate': '2014-10-14', 'studyFirstSubmitQcDate': '2014-10-14', 'lastUpdatePostDateStruct': {'date': '2014-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1998-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects with clinically relevant changes in vital signs', 'timeFrame': 'up to 8 days after drug administration'}, {'measure': 'Number of subjects with clinically relevant changes in electrocardiogram', 'timeFrame': 'up to 8 days after drug administration'}, {'measure': 'Number of subjects with clinically relevant changes in laboratory parameters', 'timeFrame': 'up to 8 days after drug administration'}, {'measure': 'Number of subjects with adverse events', 'timeFrame': 'up to 8 days after drug administration'}, {'measure': 'Determination of surrogate marker cluster of differentiation antigen 11b (CD11b) (=Mac-1)', 'timeFrame': 'up to 72 hours after drug administration'}], 'secondaryOutcomes': [{'measure': 'Changes in white blood cell count', 'timeFrame': 'up to 48 hours after drug administration', 'description': 'determined by flow cytometer'}, {'measure': 'Changes in differential blood cell count', 'timeFrame': 'up to 48 hours after drug administration', 'description': 'determined by flow cytometer'}, {'measure': 'Maximum plasma concentration (Cmax)', 'timeFrame': 'up to 72 hours after drug administration'}, {'measure': 'Time to reach maximum plasma concentration (tmax)', 'timeFrame': 'up to 72 hours after drug administration'}, {'measure': 'Area under the plasma concentration-time curve (AUC) for several time intervals', 'timeFrame': 'up to 72 hours after drug administration'}, {'measure': 'Terminal half-life (t1/2)', 'timeFrame': 'up to 72 hours after drug administration'}, {'measure': 'Total mean residence time (MRTtot)', 'timeFrame': 'up to 72 hours after drug administration'}, {'measure': 'Total clearance after oral administration (CLtot/f)', 'timeFrame': 'up to 72 hours after drug administration'}, {'measure': 'Volume of distribution during terminal phase after oral administration (Vz/f)', 'timeFrame': 'up to 72 hours after drug administration'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Study to obtain information about the safety and tolerability of BIIL 248 BS, to find the pharmacologically active dose range for the two formulations PSE 1% and WIF tablets by determination of the surrogate marker CD11b (= Mac-1) and to obtain preliminary pharmacokinetic data as well as first information on food effects after administration of the 75 mg WIF tablet in healthy male volunteers'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subjects as determined by results of screening\n* Age ≥ 21 and ≤ 50 years\n* Broca ≥ - 20% and ≤ + 20%\n* Signed written informed consent in accordance with Good Clinical Practice and local legislation\n\nExclusion Criteria:\n\n* Results of the medical examination or laboratory tests that are judged by the clinical investigator to differ significantly from normal clinical values\n* Known 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* Known 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 enrolment in the study\n* Intake of any other drugs which might influence the results of the trial during the week previous to the start of the study\n* Participation in another study with an investigational drug within the last two months preceding this study\n* Smokers (\\> 5 cigarettes or 2 cigars or 2 pipes/day)\n* Volunteer who is not able to refrain from smoking on study days\n* Alcohol abuse (more than 60 g of alcohol per day)\n* Drug abuse\n* Excessive physical activities (e.g. competitive sports) within the last week before the study\n* Blood donation within the last 4 weeks (≥ 100 ml)'}, 'identificationModule': {'nctId': 'NCT02265302', 'briefTitle': 'Safety, Tolerability, Biological Effects and Pharmacokinetics of BIIL 284 BS in Healthy Males', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability, Biological Effects and Preliminary Pharmacokinetics of Increasing Single Oral Doses of BIIL 284 BS (Dose Range: 0.025 mg - 75 mg PSE Solution, 25 mg, 75 mg, 250 mg and 750 mg WIF Tablets) in Healthy Male Volunteers as Well as Food Effects at 75 mg (WIF Tablet)', 'orgStudyIdInfo': {'id': '543.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIIL 284 BS oral solution', 'interventionNames': ['Drug: BIIL 284 oral solution']}, {'type': 'EXPERIMENTAL', 'label': 'BIIL 284 BS WIF tablets', 'interventionNames': ['Drug: BIIL 284 wetability improved formulation (WIF) tablets']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BIIL 284 oral solution', 'type': 'DRUG', 'armGroupLabels': ['BIIL 284 BS oral solution']}, {'name': 'BIIL 284 wetability improved formulation (WIF) tablets', 'type': 'DRUG', 'armGroupLabels': ['BIIL 284 BS WIF tablets']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}