Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2025-12-27 @ 10:11 PM
Study NCT ID:
NCT02222961
Status:
COMPLETED
Last Update Posted:
2014-08-22
First Post:
2014-08-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Increasing Dose Followed by Maintenance Dose Tolerance Study of BIIR 561 CL in Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C119322', 'term': 'irampanel'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'lastUpdateSubmitDate': '2014-08-21', 'studyFirstSubmitDate': '2014-08-21', 'studyFirstSubmitQcDate': '2014-08-21', 'lastUpdatePostDateStruct': {'date': '2014-08-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects with adverse events', 'timeFrame': 'up to 8 days after drug administration'}, {'measure': 'Number of subjects with clinically significant findings in vital functions', 'timeFrame': 'up to 8 days after drug administration', 'description': 'blood pressure, pulse rate, respiratory rate, oral body temperature'}, {'measure': 'Number of subjects with clinically significant findings in ECG', 'timeFrame': 'up to 8 days after drug administration'}, {'measure': 'Number of subjects with clinically significant findings in laboratory tests', 'timeFrame': 'up to 8 days after drug administration'}], 'secondaryOutcomes': [{'measure': 'Maximum concentration in plasma (Cmax)', 'timeFrame': 'up to 32 hours after first drug administration'}, {'measure': 'Time to maximum concentration in plasma (tmax)', 'timeFrame': 'up to 32 hours after first drug administration'}, {'measure': 'Terminal half-life (t1/2)', 'timeFrame': 'up to 32 hours after first drug administration'}, {'measure': 'Area under the plasma concentration-time curve from zero to the last time points with a quantifiable plasma concentration (AUC0-tf)', 'timeFrame': 'up to 32 hours after first drug administration'}, {'measure': 'Area under the plasma concentration-time curve extrapolated to infinity (AUC0-inf)', 'timeFrame': 'up to 32 hours after first drug administration'}, {'measure': 'Total Mean residence time (MRTtot)', 'timeFrame': 'up to 32 hours after first drug administration'}, {'measure': 'Total plasma clearance (CLtot)', 'timeFrame': 'up to 32 hours after first drug administration'}, {'measure': 'Volume of distribution (Vz)', 'timeFrame': 'up to 32 hours after first drug administration'}, {'measure': 'Volume of distribution at steady state (Vss)', 'timeFrame': 'up to 32 hours after first drug administration'}, {'measure': 'Amount excreted into urine (Ae)', 'timeFrame': 'up to 32 hours after first drug administration'}, {'measure': 'Mean residence time of disposition (MRTdisp)', 'timeFrame': 'up to 32 hours after first drug administration'}, {'measure': 'Renal clearance (CLR)', 'timeFrame': 'up to 32 hours after first drug administration'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective of the present study is to obtain information about the safety, tolerability and pharmacokinetics of BIIR 561 after continuous intravenous administration of increasing doses in healthy young volunteers'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male volunteers\n* Age 21 to 50 years\n* Broca index from -20% to +20%\n* Written informed consent prior to admission to the study\n\nExclusion Criteria:\n\n* Medical examination, laboratory tests or ECG judged by the investigator to differ significantly from normal clinical values\n* Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n* Known diseases of the central nervous system (CNS) (such as epilepsy), CNS trauma in their medical history or with psychiatric or neurological disorders\n* Known history of orthostatic hypotension, fainting spells or blackouts\n* Chronic or relevant acute infections\n* 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 drug 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* Smoker (\\> 10 cigarettes or 3 cigars or 3 pipes/day)\n* Alcohol use of more than 60 g per day\n* Drug dependency\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': 'NCT02222961', 'briefTitle': 'Single Increasing Dose Followed by Maintenance Dose Tolerance Study of BIIR 561 CL in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Single-blind, Placebo-controlled Single Increasing Dose Tolerance Study in Healthy Male Volunteers After Intravenous Administration of BIIR 561 CL as Loading Dose (Dosage: 37.5 mg/h - 150 mg/h, Infusion Time 1 Hour) Followed by Maintenance Dose (Dosage: 20 mg/h - 40 to 125 mg/h), Infusion Time 5 Hours', 'orgStudyIdInfo': {'id': '600.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIIR 561 CL', 'interventionNames': ['Drug: BIIR 561 CL']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BIIR 561 CL', 'type': 'DRUG', 'armGroupLabels': ['BIIR 561 CL']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}