Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-01-28 @ 5:32 PM
Study NCT ID:
NCT02269202
Status:
COMPLETED
Last Update Posted:
2014-10-21
First Post:
2014-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Midazolam, With and Without Concomitant Administration of Crobenetine in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}, {'id': 'C408069', 'term': 'BIII 890 CL'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'lastUpdateSubmitDate': '2014-10-20', 'studyFirstSubmitDate': '2014-10-16', 'studyFirstSubmitQcDate': '2014-10-20', 'lastUpdatePostDateStruct': {'date': '2014-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the concentration-time curve of midazolam from zero time extrapolated to infinity (AUC0-infinity)', 'timeFrame': 'up to 24 hours after start of drug administration'}, {'measure': 'Maximum observed concentration of midazolam in plasma (Cmax)', 'timeFrame': 'up to 24 hours after start of drug administration'}], 'secondaryOutcomes': [{'measure': 'Area under the concentration-time curve (AUC)', 'timeFrame': 'up to 24 hours after start of drug administration'}, {'measure': 'Time to maximum observed concentration (tmax)', 'timeFrame': 'up to 24 hours after start of drug administration'}, {'measure': 'Individual time courses of plasma concentrations', 'timeFrame': 'up to 24 hours after start of drug administration'}, {'measure': 'Terminal rate constant in plasma (λz)', 'timeFrame': 'up to 24 hours after start of drug administration'}, {'measure': 'Terminal half-life in plasma (t1/2)', 'timeFrame': 'up to 24 hours after start of drug administration'}, {'measure': 'Mean residence time in the body (MRT)', 'timeFrame': 'up to 24 hours after start of drug administration'}, {'measure': 'Apparent clearance in plasma (CL/F)', 'timeFrame': 'up to 24 hours after start of drug administration'}, {'measure': 'Volume of distribution (V)', 'timeFrame': 'up to 24 hours after start of drug administration'}, {'measure': 'Changes from baseline in physical examination', 'timeFrame': 'pre-dose and day 8 after drug administration'}, {'measure': 'Number of patients with clinically relevant findings in vital signs', 'timeFrame': 'up to day 8 after drug administration', 'description': 'blood pressure, pulse rate'}, {'measure': 'Number of patients with clinically relevant findings in 12-lead ECG', 'timeFrame': 'up to day 8 after drug administration'}, {'measure': 'Number of patients with clinically relevant findings in laboratory tests', 'timeFrame': 'up to day 8 after drug administration'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'up to day 8 after drug administration'}, {'measure': 'Global assessment of tolerability by the investigator on a 4-point rating scale', 'timeFrame': 'up to 192 hours after start of drug administration'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To assess the pharmacokinetics of midazolam with/without concomitant administration of crobenetine'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- All 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\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 (except substitution therapy regarding thyroid gland)\n* Use of any drugs that 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'}, 'identificationModule': {'nctId': 'NCT02269202', 'briefTitle': 'Pharmacokinetics of Midazolam, With and Without Concomitant Administration of Crobenetine in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Pharmacokinetics of 7.5 mg Midazolam, Given Orally 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 Randomised, Single Blind, Two-way Crossover Trial in Healthy Male Subjects', 'orgStudyIdInfo': {'id': '599.12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Midazolam and crobenetine', 'interventionNames': ['Drug: Midazolam, tablet', 'Drug: Crobenetine, i.v. infusion']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Midazolam and placebo', 'interventionNames': ['Drug: Midazolam, tablet', 'Drug: Placebo']}], 'interventions': [{'name': 'Midazolam, tablet', 'type': 'DRUG', 'armGroupLabels': ['Midazolam and crobenetine', 'Midazolam and placebo']}, {'name': 'Crobenetine, i.v. infusion', 'type': 'DRUG', 'armGroupLabels': ['Midazolam and crobenetine']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Midazolam and placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}