Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-01 @ 10:45 AM
Study NCT ID:
NCT02268604
Status:
TERMINATED
Last Update Posted:
2014-10-20
First Post:
2014-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Pharmacodynamics, and Pharmacokinetics After Multiple Different Oral Doses of BIIB 722 CL Tablets in Healthy 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': 10}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'lastUpdateSubmitDate': '2014-10-16', 'studyFirstSubmitDate': '2014-08-21', 'studyFirstSubmitQcDate': '2014-10-16', 'lastUpdatePostDateStruct': {'date': '2014-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the concentration-time curve of the analyte in plasma (AUC)', 'timeFrame': 'up to day 7'}, {'measure': 'Maximum measured concentration of the analyte in plasma (Cmax)', 'timeFrame': 'up to day 7'}, {'measure': 'Time to maximum measured concentration of the analyte in plasma (tmax)', 'timeFrame': 'up to day 7'}, {'measure': 'Total mean residence time of the analyte in the body (MRTtot)', 'timeFrame': 'up to day 7'}, {'measure': 'Total clearance of the analyte in plasma (CLtot/f)', 'timeFrame': 'up to day 7'}, {'measure': 'Terminal half-life of the analyte in plasma (t1/2)', 'timeFrame': 'up to day 7'}, {'measure': 'Amount of the analyte excreted in urine (Ae)', 'timeFrame': 'up to day 7'}, {'measure': 'Dose proportionality', 'timeFrame': 'up to day 7', 'description': 'assessed by AUC'}, {'measure': 'Accumulation factor', 'timeFrame': 'up to day 7', 'description': '(predose concentration/concentration after 8 hours)'}, {'measure': 'Time to reach steady state', 'timeFrame': 'up to day 7'}, {'measure': 'Thrombocytic Na-H exchange (NHE-1) inhibition by AUC of pH recovery', 'timeFrame': 'up to day 7', 'description': 'in vitro fluorescence'}], 'secondaryOutcomes': [{'measure': 'Number of subjects with adverse events', 'timeFrame': 'up to day 12'}, {'measure': 'Number of subjects with clinically significant findings in vital functions', 'timeFrame': 'up to day 12'}, {'measure': 'Number of subjects with clinically significant findings in laboratory tests', 'timeFrame': 'up to day 12'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Study to assess safety, pharmacodynamics and pharmacokinetics of BIIB 722 CL'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males\n* 18 to 55 years of age\n* Broca index \\>= -20% and \\<= +20%\n* Written informed consent according to Good Clinical Practice (GCP) and local legislation\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* History or current gastrointestinal hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders\n* History of orthostatic hypotension, fainting spells or 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\n* Use of any drugs, which might influence the results of the trial within 10 days prior to administration or during the trial\n* Participation in another trial with an investigational drug within 2 months prior to administration of during trial\n* Smoker (\\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days\n* Alcohol abuse (\\> 60 g/day)\n* Drug abuse\n* Blood donation 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 clinically accepted reference range'}, 'identificationModule': {'nctId': 'NCT02268604', 'briefTitle': 'Safety, Pharmacodynamics, and Pharmacokinetics After Multiple Different Oral Doses of BIIB 722 CL Tablets in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Safety, Pharmacodynamics, and Pharmacokinetics After Multiple Oral Doses of 200 and 300 mg BIIB 722 CL Tablet Tid and 300 and 450 mg BIIB 722 CL Tablet Bid Over 7 Days to Healthy Volunteer Subjects. An Open Study, Placebo-controlled Randomised Double Blind at Each Dose Level.', 'orgStudyIdInfo': {'id': '1180.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIIB 722 CL', 'interventionNames': ['Drug: BIIB 722 CL']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BIIB 722 CL', 'type': 'DRUG', 'armGroupLabels': ['BIIB 722 CL']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}