Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-10 @ 4:34 PM
Study NCT ID:
NCT02208856
Status:
COMPLETED
Last Update Posted:
2014-08-05
First Post:
2014-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Pharmacokinetics and Pharmacodynamics of Single Rising Doses Oral BIRB 796 BS in Healthy Human Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'lastUpdateSubmitDate': '2014-08-04', 'studyFirstSubmitDate': '2014-08-04', 'studyFirstSubmitQcDate': '2014-08-04', 'lastUpdatePostDateStruct': {'date': '2014-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1999-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects with clinically relevant changes in vital signs', 'timeFrame': 'Baseline, up to 96 hours after drug administration'}, {'measure': 'Number of subjects with clinically relevant changes in laboratory measurements', 'timeFrame': 'Baseline, up to 96 hours after drug administration'}, {'measure': 'Number of subjects with clinically relevant changes in electrocardiograms (ECG)', 'timeFrame': 'Baseline, up to 96 hours after drug administration'}, {'measure': 'Number of subjects with adverse events', 'timeFrame': 'up to 96 hours after drug administration'}], 'secondaryOutcomes': [{'measure': 'Maximum concentration of the analyte in plasma (Cmax)', 'timeFrame': 'up to 48 hours after drug administration'}, {'measure': 'Area under the concentration-time curve of the analyte in plasma from time zero to infinity (AUC0-inf)', 'timeFrame': 'up to 48 hours after drug administration'}, {'measure': 'Time from dosing to the maximum concentration of the analyte in plasma (Tmax)', 'timeFrame': 'up to 48 hours after drug administration'}, {'measure': 'Terminal rate constant of the analyte in plasma (λz)', 'timeFrame': 'up to 48 hours after drug administration'}, {'measure': 'Half life of the analyte in plasma (t1/2)', 'timeFrame': 'up to 48 hours after drug administration'}, {'measure': 'Mean residence time of the analyte in the body (MRTtot)', 'timeFrame': 'up to 48 hours after drug administration'}, {'measure': 'Apparent clearance of the analyte in plasma (CL/F)', 'timeFrame': 'up to 96 hours after drug administration'}, {'measure': 'Apparent volume of distribution during the terminal phase λz (Vz/F)', 'timeFrame': 'up to 48 hours after drug administration'}, {'measure': 'Mac-1/L selectin ratio of formyl-methionyl-leucyl-phenylalanine (fMLP)-stimulated to unstimulated neutrophils', 'timeFrame': 'up to 48 hours after drug administration'}, {'measure': 'Mac-1/L selectin ratio of TNFalpha-stimulated to unstimulated neutrophils', 'timeFrame': 'up to 48 hours after drug administration'}, {'measure': 'Percent changes in TNFalpha production', 'timeFrame': 'up to 48 hours after drug administration', 'description': 'after ex vivo stimulation of whole blood with endotoxin'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To assess safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating single doses, with and without a 64 g fat breakfast at one selected dose.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subjects as determined by results of screening\n* Signed written informed consent in accordance with good clinical practice (GCP) and local legislation\n* Age \\>= 18 and \\<= 45 years\n* Broca \\>= -20% and \\<= +20%\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* Surgery of gastrointestinal tract (except appendectomy)\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 ot the trial as judged by the investigator\n* Intake of drugs with a long half-life (\\> 24 hours) (= 1 month prior to administration or during the trial)\n* Use of any drugs, which might influence the results of the trial (= 10 days prior to administration or during the trial)\n* Participation in another trial with an investigational drug (=2 months prior to administration or during trial)\n* Smoker (\\> 10 cigarettes of \\> 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 \\> 400 ml (=1 month prior to administration of during the trial)\n* Excessive physical activities (= 5 days prior to administration or during the trial)\n* Any laboratory value outside the reference range of clinical relevance (but not exclusive to) total white cell count \\>= 10 x 10\\*\\*9/L, C-reactive protein \\>= 4.5 mg/L, any haemoglobin or \\> 15 mg/dl protein on urine dipstick\n* History of any familial bleeding disorder'}, 'identificationModule': {'nctId': 'NCT02208856', 'briefTitle': 'Safety, Pharmacokinetics and Pharmacodynamics of Single Rising Doses Oral BIRB 796 BS in Healthy Human Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Safety, Pharmacokinetics and Pharmacodynamics of Single Rising Doses (1, 4, 15, 50, 100, 200, 400, and 600 mg) Oral BIRB 796 BS in Healthy Human Subjects. A Placebo Controlled, Randomised Study, Double Blinded at Each Dose Level', 'orgStudyIdInfo': {'id': '1175.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BIBR 796 BS food effect', 'interventionNames': ['Drug: BIBR 796 BS', 'Other: high fat standardized breakfast']}, {'type': 'EXPERIMENTAL', 'label': 'BIBR 796 BS', 'interventionNames': ['Drug: BIBR 796 BS']}], 'interventions': [{'name': 'BIBR 796 BS', 'type': 'DRUG', 'armGroupLabels': ['BIBR 796 BS', 'BIBR 796 BS food effect']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}, {'name': 'high fat standardized breakfast', 'type': 'OTHER', 'armGroupLabels': ['BIBR 796 BS food effect']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}