Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-27 @ 6:56 PM
Study NCT ID:
NCT02211157
Status:
COMPLETED
Last Update Posted:
2014-08-08
First Post:
2014-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Pharmacokinetics and Pharmacodynamics of BIRB 796 BS Tablets Administered to 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': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'lastUpdateSubmitDate': '2014-08-07', 'studyFirstSubmitDate': '2014-08-05', 'studyFirstSubmitQcDate': '2014-08-05', 'lastUpdatePostDateStruct': {'date': '2014-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with clinically relevant changes in laboratory parameters', 'timeFrame': 'up to day 16'}, {'measure': 'Number of patients with abnormal findings in electrocardiogram (ECG)', 'timeFrame': 'up to day 16'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'up to 30 days'}, {'measure': 'Assessment of tolerability on a 4-point scale', 'timeFrame': 'day 16'}, {'measure': 'Number of patients with clinically relevant changes in vital signs', 'timeFrame': 'up to 16 days'}], 'secondaryOutcomes': [{'measure': 'Maximum plasma concentration (Cmax) for several time points', 'timeFrame': 'up to day 9'}, {'measure': 'Area under the plasma concentration-time curve (AUC) for several time points', 'timeFrame': 'up to day 9'}, {'measure': 'Time to maximum concentration (tmax)', 'timeFrame': 'up to day 9'}, {'measure': 'Elimination rate constant (λz)', 'timeFrame': 'up to day 9'}, {'measure': 'Terminal half-life (t1/2)', 'timeFrame': 'up to day 9'}, {'measure': 'Mean residence time (MRT)', 'timeFrame': 'up to day 9'}, {'measure': 'Apparent clearance (CL/f)', 'timeFrame': 'up to day 9'}, {'measure': 'Apparent volume of distribution (Vz/F)', 'timeFrame': 'up to day 9'}, {'measure': 'Assessment of neutrophil and monocyte activation by ex vivo stimulation of whole blood with formyl-methionyl-leucyl-phenylalanine (fMLP)', 'timeFrame': 'up to day 9', 'description': 'Change in the Mac-1 / L-selectin ratio'}, {'measure': 'Assessment of neutrophil and monocyte activation by ex vivo stimulation of whole blood with tumour necrosis factor (TNF) α', 'timeFrame': 'up to day 9', 'description': 'Change in the Mac-1 / L-selectin ratio'}, {'measure': 'Assessment of TNFα production by ex vivo stimulation of whole blood with endotoxin', 'timeFrame': 'up to day 9'}, {'measure': 'Changes in cellular immune response measured by Multitest®', 'timeFrame': 'Day 8'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Study to assess safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating multiple doses with and without a 64 g fat breakfast at the 50 mg dose level'}, '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 and local legislation\n* Age ≥ 18 and ≤ 45 years\n* Broca ≥ - 20% and ≤ + 20%\n\nExclusion Criteria:\n\n* Any findings 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, immunologic, hormonal disorders\n* Surgery of gastrointestinal tract (except appendectomy)\n* History of orthostatic hypotension, fainting spells and blackouts\n* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders\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 1 month prior to administration or during the trial)\n* Use of any drugs which might influence the results of the trial within 10 days prior to administration or during trial\n* Participation in another trial with an investigational drug within 2 months prior to administration or during trial\n* Smoker (\\> 10 cigarettes or 3 cigars or 3 pipes/day)\n* Inability to refrain from smoking on study days\n* Alcohol abuse (\\> 60 g/day)\n* Drug abuse\n* Blood donation \\> 400 ml within 1 month prior to administration or during the trial\n* Excessive physical activities within 5 days prior to administration or during the trial\n* Any laboratory value outside the reference range of clinical relevance including, but not limited to total white cell count ≥ 10 x 10\\*\\*9/L, C-reactive protein ≥ 4.5 mg/L, Gamma-Glutamyl Transferase ≥ 40 U/L, any hemoglobin or \\> 15 mg/dl protein or urine dipstick, abnormal Multitest® assessment of cellular immunity\n* History of any familial bleeding disorder\n* Inability to comply with dietary regimen of study centre'}, 'identificationModule': {'nctId': 'NCT02211157', 'briefTitle': 'Safety, Pharmacokinetics and Pharmacodynamics of BIRB 796 BS Tablets Administered to Healthy Human Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Safety, Pharmacokinetics and Pharmacodynamics of BIRB 796 BS Tablets (20, 30, 150, 300, and 600 mg) Administered Orally to Healthy Human Subjects Once Daily for 7 Days. A Placebo Controlled, Randomised, Double Blinded Study', 'orgStudyIdInfo': {'id': '1175.3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIBR 796 BS, fasted', 'description': 'dose escalation', 'interventionNames': ['Drug: BIBR 796 BS']}, {'type': 'EXPERIMENTAL', 'label': 'BIBR 796 BS, fed', 'description': '50 mg BIRB 796 BS (food effect)', 'interventionNames': ['Drug: BIBR 796 BS', 'Other: high fat breakfast']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BIBR 796 BS', 'type': 'DRUG', 'armGroupLabels': ['BIBR 796 BS, fasted', 'BIBR 796 BS, fed']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}, {'name': 'high fat breakfast', 'type': 'OTHER', 'armGroupLabels': ['BIBR 796 BS, fed']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}