Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-01-11 @ 3:33 PM
Study NCT ID:
NCT02209805
Status:
COMPLETED
Last Update Posted:
2014-08-06
First Post:
2014-08-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetics of BIRB 796 BS Tablets Administered to Healthy Human Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C452139', 'term': 'doramapimod'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'lastUpdateSubmitDate': '2014-08-05', 'studyFirstSubmitDate': '2014-08-05', 'studyFirstSubmitQcDate': '2014-08-05', 'lastUpdatePostDateStruct': {'date': '2014-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with clinically significant changes in vital signs', 'timeFrame': 'up to 21 days'}, {'measure': 'Number of patients with clinically significant changes in laboratory parameters', 'timeFrame': 'up to 21 days'}, {'measure': 'Number of patients with abnormal findings in electrocardiogram', 'timeFrame': 'up to 21 days'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'up to 24 days'}], 'secondaryOutcomes': [{'measure': 'Maximum concentration of the analyte in plasma (Cmax) for several time points', 'timeFrame': 'up to 36 hours after dosing'}, {'measure': 'Area under the plasma concentration versus time curve (AUC) for several time points', 'timeFrame': 'up to 36 hours after dosing'}, {'measure': 'Time at which maximum plasma concentration occurred over a dosing interval (tmax)', 'timeFrame': 'up to 36 hours after dosing'}, {'measure': 'Terminal elimination rate constant (λZ)', 'timeFrame': 'up to 36 hours after dosing'}, {'measure': 'Elimination half-life (t1/2)', 'timeFrame': 'up to 36 hours after dosing'}, {'measure': 'Mean residence time (MRT)', 'timeFrame': 'up to 36 hours after dosing'}, {'measure': 'Apparent oral clearance (CL/F)', 'timeFrame': 'up to 36 hours after dosing'}, {'measure': 'Apparent volume of distribution during the terminal elimination phase, divided by F (bioavailability factor) (Vz/F)', 'timeFrame': 'up to 36 hours after dosing'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Study to assess the safety and pharmacokinetics of BIRB 796 BS tablets administered as multiple daily doses at various dose levels.'}, '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* Able to communicate well with the investigator and to comply with study requirements\n* \\> 10 elimination half lives present since last use of any investigational drug for that investigational drug\n* Laboratory values within a clinically relevant reference range\n\nExclusion Criteria:\n\n* Any finding of the medical examination (including blood pressure, pulse rate, temperature, and EKG) 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 to the trial as judged by the investigator\n* History of vasculitis (past history of fever, malaise, myalgias, rash, etc.)\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 (\\< 1 months prior to administration or during trial)\n* Smoker\n* Inability to refrain from smoking on trial days\n* Alcohol abuse (\\> 60 g/day)\n* Drug abuse\n* Use of methylxanthine-containing drinks or foods (coffee, tea, cola, energy drinks, chocolate, etc.) \\< one week prior to administration of study drug\n* Blood donation or loss \\> 400 mL (\\< 1 month prior to administration or during the trial)\n* Excessive physical activities (\\< 5 days prior to administration or during the trial)\n* Following specific laboratory findings: total white blood cell \\>= 10 x 109/L, C-Reactive Protein \\>= 4.5 mg/L, gamma-glutamyl-transferase \\>= 25 U/L, aspartate transaminase \\>= 16 U/L, alanine transaminase \\>= 20 U/L any erythrocytes or \\> 15 mg/dl protein on urine dipstick\n* Any EKG value outside of the reference range of clinical relevance including, but not limited to QTcB \\> 480 ms, PR interval \\> 240 ms, QRS interval \\> 110 ms\n* History of any familial bleeding disorder\n* Inability to comply with dietary regimen of study centre\n* Inability to comply with investigator's instructions"}, 'identificationModule': {'nctId': 'NCT02209805', 'briefTitle': 'Safety and Pharmacokinetics of BIRB 796 BS Tablets Administered to Healthy Human Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Safety and Pharmacokinetics of BIRB 796 BS Tablets Administered Twice Daily Orally (Total Daily Dose 30, 60, and 120 mg) to Healthy Human Subjects for 14 Days. A Double-blind, Placebo-controlled, Parallel Group Study.', 'orgStudyIdInfo': {'id': '1175.14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIRB 796 BS, low dose', 'interventionNames': ['Drug: BIRB 796 BS, low dose']}, {'type': 'EXPERIMENTAL', 'label': 'BIRB 796 BS, high dose', 'interventionNames': ['Drug: BIRB 796 BS, high dose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BIRB 796 BS, medium dose', 'interventionNames': ['Drug: BIRB 796 BS, low dose', 'Drug: BIRB 796 BS, high dose']}], 'interventions': [{'name': 'BIRB 796 BS, low dose', 'type': 'DRUG', 'armGroupLabels': ['BIRB 796 BS, low dose', 'BIRB 796 BS, medium dose']}, {'name': 'BIRB 796 BS, high dose', 'type': 'DRUG', 'armGroupLabels': ['BIRB 796 BS, high dose', 'BIRB 796 BS, medium dose']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}