Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-03-13 @ 8:09 PM
Study NCT ID:
NCT02259894
Status:
COMPLETED
Last Update Posted:
2014-10-09
First Post:
2014-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Pharmacokinetics, and Pharmacodynamics of BIRT 2584 XX in Healthy Male Volunteers
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': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'lastUpdateSubmitDate': '2014-10-07', 'studyFirstSubmitDate': '2014-10-07', 'studyFirstSubmitQcDate': '2014-10-07', 'lastUpdatePostDateStruct': {'date': '2014-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': 'Up to 16 days after drug administration'}, {'measure': 'Number of participants with clinically significant changes in vital signs', 'timeFrame': 'Up to 16 days after drug administration'}, {'measure': 'Number of participants with abnormal changes in clinical laboratory parameters', 'timeFrame': 'Up to 16 days after drug administration'}, {'measure': 'Number of participants with abnormal findings in 12-lead ECG (electrocardiogram)', 'timeFrame': 'Up to 16 days after drug administration'}, {'measure': 'Number of participants with abnormal findings in physical examination', 'timeFrame': 'Screening and up to 16 days after drug administration'}], 'secondaryOutcomes': [{'measure': 'Cmax (maximum concentration in plasma)', 'timeFrame': 'Up to 360 hours after drug administration'}, {'measure': 'tmax (time from dosing to maximum concentration)', 'timeFrame': 'Up to 360 hours after drug administration'}, {'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 360 hours after drug administration'}, {'measure': 'AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time) interval from 0 to the last quantifiable analyte plasma concentration)', 'timeFrame': 'Up to 360 hours after drug administration'}, {'measure': 'λz (terminal rate constant in plasma)', 'timeFrame': 'Up to 360 hours after drug administration'}, {'measure': 't1/2 (terminal half-life of the analyte in plasma)', 'timeFrame': 'Up to 360 hours after drug administration'}, {'measure': 'MRT(mean residence time of the analyte in the body)', 'timeFrame': 'Up to 360 hours after drug administration'}, {'measure': 'CL/F (apparent oral clearance in plasma after oral administration)', 'timeFrame': 'Up to 360 hours after drug administration'}, {'measure': 'Vz/F (apparent volume of distribution during the terminal phase λz) dose)', 'timeFrame': 'Up to 360 hours after drug administration'}, {'measure': 'Ae0-48 (amount of analyte that is eliminated in urine from 0-48 hours)', 'timeFrame': 'Up to 48 hours after drug administration'}, {'measure': 'fe0-48 (fraction of analyte eliminated in urine from 0-48 hours)', 'timeFrame': 'Up to 48 hours after drug administration'}, {'measure': 'CLR,0-48 (renal clearance of the analyte from 0-48 hours)', 'timeFrame': 'Up to 48 hours after drug administration'}, {'measure': 'Receptor occupancy as determined by binding of anti-LFA-1 antibody fragment (Fab)', 'timeFrame': 'Up to 360 hours after drug administration'}, {'measure': 'Inhibition of IL-2 production', 'timeFrame': 'Up to 360 hours after drug administration', 'description': 'in response to superantigen challenge ex vivo'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To assess safety, tolerability, pharmacokinetics, and pharmacodynamics of BIRT 2584 XX in single rising oral doses of 5 mg to 700 mg in a polyethylene glycol 400 (PEG 400) solution in healthy subjects'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 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 \\<=50 years\n* BMI \\>=18.5 and \\<=29.9 kg/m2\n\nExclusion Criteria:\n\n* Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance\n* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, haematological, oncological 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* Relevant 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 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 study drug administration or expected during the trial)\n* Participation in another trial with an investigational drug (\\< 2 months prior to administration or expected during trial)\n* Smoker (\\> 10 cigarettes or \\>3 cigars or \\>3 pipes/day)\n* Alcohol abuse (\\> 60 g/day)\n* Drug abuse\n* Blood donation or loss \\> 400 mL, \\< 1 month prior to administration or expected during the trial\n* Clinically relevant laboratory abnormalities\n* Any ECG value outside of the reference range and of clinical relevance including, but not limited to QRS interval \\> 110 ms or QT interval, Bazett correction (QTcB) \\> 450 ms or QT interval \\>500 ms\n* Inability to comply with dietary regimen of study centre\n* Inability to comply with investigator's instructions"}, 'identificationModule': {'nctId': 'NCT02259894', 'briefTitle': 'Safety, Pharmacokinetics, and Pharmacodynamics of BIRT 2584 XX in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Safety, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses of BIRT 2584 XX (5, 30, 100, 200, 350, 500, and 700 mg) as a Solution in PEG 400 Administered to Healthy Male Volunteers. Placebo Controlled and Blinded at Each Dose Level.', 'orgStudyIdInfo': {'id': '1206.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIRT 2584', 'description': 'single rising doses', 'interventionNames': ['Drug: BIRT 2584 XX']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BIRT 2584 XX', 'type': 'DRUG', 'armGroupLabels': ['BIRT 2584']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}