Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2026-04-17 @ 10:22 PM
Study NCT ID:
NCT02273466
Status:
COMPLETED
Last Update Posted:
2014-10-24
First Post:
2014-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Oral Desipramine With and Without Concomitant Administration of Crobenetine Infusion in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003891', 'term': 'Desipramine'}], 'ancestors': [{'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'lastUpdateSubmitDate': '2014-10-23', 'studyFirstSubmitDate': '2014-10-23', 'studyFirstSubmitQcDate': '2014-10-23', 'lastUpdatePostDateStruct': {'date': '2014-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the concentration time curve for desipramine at steady state (AUC,ss)', 'timeFrame': 'up to 168 hours after start of drug administration'}, {'measure': 'Maximum plasma concentration of desipramine at steady state (Cmax,ss)', 'timeFrame': 'up to 168 hours after start of drug administration'}], 'secondaryOutcomes': [{'measure': 'Individual time courses of plasma concentrations', 'timeFrame': 'up to 168 hours after start of drug administration'}, {'measure': 'Area under the concentration time curve from zero time to time of last quantifiable drug concentration (AUC0-tz)', 'timeFrame': 'up to 168 hours after start of drug administration'}, {'measure': 'Area under the concentration time curve from zero time extrapolated to infinity(AUC0-infinity)', 'timeFrame': 'up to 168 hours after start of drug administration'}, {'measure': 'Time to reach maximum concentration of desipramine at steady state (tmax,ss)', 'timeFrame': 'up to 168 hours after start of drug administration'}, {'measure': 'Apparent terminal rate constant (λz)', 'timeFrame': 'up to 168 hours after start of drug administration'}, {'measure': 'Apparent terminal half-live in plasma (t1/2)', 'timeFrame': 'up to 168 hours after start of drug administration'}, {'measure': 'Mean residence time (MRT)', 'timeFrame': 'up to 168 hours after start of drug administration'}, {'measure': 'Total clearance (CL)', 'timeFrame': 'up to 168 hours after start of drug administration'}, {'measure': 'Apparent volume of distribution (V)', 'timeFrame': 'up to 168 hours after start of drug administration'}, {'measure': 'Observed concentration of crobenetine (C,h)', 'timeFrame': '1 and 6 hours after start of infusion'}, {'measure': 'Number of subjects with adverse events', 'timeFrame': 'up to 8 days after last drug administration'}, {'measure': 'Number of subjects with clinically significant findings in vital signs', 'timeFrame': 'up to 8 days after last drug administration', 'description': 'blood pressure, pulse rate'}, {'measure': 'Number of subjects with clinically significant findings in 12-lead ECG', 'timeFrame': 'up to 8 days after last drug administration'}, {'measure': 'Number of subjects with clinically significant findings in laboratory tests', 'timeFrame': 'up to 8 days after last drug administration'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To assess the steady state pharmacokinetics of Desipramine with/without concomitant administration of Crobenetine.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll participants in the study should be healthy males, range from 21 to 50 years of age and their bodymass index (BMI) be within 18.5 to 29.9 kg/m2.\n\nIn accordance with Good Clinical Practice and local legislation all volunteers will have given their written informed consent prior to admission to the study.\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* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders\n* History of relevant 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) within at least one month or less than ten half-lives of the respective drug before enrolment in the study\n* Use of any drugs which might influence the results of the trial (within one week prior to administration or during the trial)\n* Participation in another trial with an investigational drug (within two months prior to administration or during the trial)\n* Smoker (\\> 10 cigarettes or \\> 3 cigars or \\> 3 pipes/day)\n* Inability to refrain from smoking on trial days\n* Alcohol abuse (\\> 60 g/day)\n* Drug abuse\n* Blood donation (\\>= 100 mL within four weeks prior to administration or during the trial)\n* Excessive physical activities (within the last week before the study)\n* Any laboratory value outside the reference range of clinical relevance\n* Cytochrome P450 2D6 poor metaboliser (to be determined by phenotyping or genotyping)'}, 'identificationModule': {'nctId': 'NCT02273466', 'briefTitle': 'Pharmacokinetics of Oral Desipramine With and Without Concomitant Administration of Crobenetine Infusion in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Pharmacokinetics of 50 mg Desipramine Daily, Given Orally Over 7 Days With and Without Concomitant Administration of 175 mg Crobenetine, Given as a 6 Hrs i.v. Infusion (One Hour Loading Dose Directly Followed by a Five Hours Maintenance Dose). A Randomized, Placebo Controlled, Single Blind (for Crobenetine), Two-way Cross Over Trial in Healthy Male Subjects', 'orgStudyIdInfo': {'id': '599.11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Desipramine alone', 'interventionNames': ['Drug: Desipramine tablet', 'Drug: Placebo infusion']}, {'type': 'EXPERIMENTAL', 'label': 'Desipramine with Crobenetine', 'interventionNames': ['Drug: Desipramine tablet', 'Drug: Crobenetine infusion']}], 'interventions': [{'name': 'Desipramine tablet', 'type': 'DRUG', 'armGroupLabels': ['Desipramine alone', 'Desipramine with Crobenetine']}, {'name': 'Crobenetine infusion', 'type': 'DRUG', 'armGroupLabels': ['Desipramine with Crobenetine']}, {'name': 'Placebo infusion', 'type': 'DRUG', 'armGroupLabels': ['Desipramine alone']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}