Ignite Creation Date:
2025-12-24 @ 2:27 PM
Ignite Modification Date:
2026-04-22 @ 1:35 PM
Study NCT ID:
NCT02259959
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, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Inhalative Doses of BI 1744 CL in Fixed Dose Combination With Tiotropium Bromide in Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012996', 'term': 'Solutions'}, {'id': 'D001239', 'term': 'Inhalation'}, {'id': 'D000069447', 'term': 'Tiotropium Bromide'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D015656', 'term': 'Respiratory Mechanics'}, {'id': 'D012119', 'term': 'Respiration'}, {'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}, {'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, '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': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects with clinically relevant findings in physical examination', 'timeFrame': 'Up to day 32'}, {'measure': 'Number of subjects with clinically relevant findings in vital signs', 'timeFrame': 'Up to day 32', 'description': 'blood pressure, pulse rate'}, {'measure': 'Number of subjects with clinically relevant findings in 12-lead ECG', 'timeFrame': 'Up to day 32'}, {'measure': 'Number of subjects with clinically relevant findings in laboratory tests', 'timeFrame': 'Up to day 32'}, {'measure': 'Number of subjects witch clinically relevant changes in additional safety laboratory test parameters', 'timeFrame': 'up to 318 hours after start of treatment', 'description': 'Systemic metabolic parameters: cyclic adenosine mono phosphate (cAMP) and potassium'}, {'measure': 'Number of subjects with clinically relevant changes in airway resistance (Raw) measured by body plethysmography', 'timeFrame': 'Pre-dose, up to 408 hours after start of treatment'}, {'measure': 'Number of subjects with adverse events', 'timeFrame': 'Up to day 32'}, {'measure': 'Global assessment of tolerability by investigator on a 4-point scale', 'timeFrame': 'Up to day 32'}], 'secondaryOutcomes': [{'measure': 'Maximum concentration in plasma (Cmax)', 'timeFrame': 'up to 504 hours after start of treatment'}, {'measure': 'Time from dosing to maximum concentration in plasma (tmax)', 'timeFrame': 'up to 504 hours after start of treatment'}, {'measure': 'Area under the concentration-time curve in plasma (AUC)', 'timeFrame': 'up to 504 hours after start of treatment'}, {'measure': 'Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)', 'timeFrame': 'up to 504 hours after start of treatment'}, {'measure': 'Percentage of AUC 0-∞ that is obtained by extrapolation (%AUCtz-∞)', 'timeFrame': 'up to 504 hours after start of treatment'}, {'measure': 'Terminal rate constant in plasma (λz)', 'timeFrame': 'up to 504 hours after start of treatment'}, {'measure': 'Terminal half-life in plasma (t½)', 'timeFrame': 'up to 504 hours after start of treatment'}, {'measure': 'Mean residence time in the body after inhalation (MRTih)', 'timeFrame': 'up to 504 hours after start of treatment'}, {'measure': 'Apparent clearance after extravascular administration (CL/F)', 'timeFrame': 'up to 504 hours after start of treatment'}, {'measure': 'Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)', 'timeFrame': 'up to 504 hours after start of treatment'}, {'measure': 'Amount eliminated in urine from the time point t1 to t2 (Aet1-t2)', 'timeFrame': 'up to 336 hours after start of treatment'}, {'measure': 'Fraction excreted in urine from time point t1 to t2 (fet1-t2)', 'timeFrame': 'up to 336 hours after start of treatment'}, {'measure': 'Renal clearance from the time point t1 until the time point t2 (CLR,t1-t2)', 'timeFrame': 'up to 504 hours after start of treatment'}, {'measure': 'Minimum measured concentration in plasma at steady state over a uniform dosing interval τ (Cmin,ss)', 'timeFrame': 'up to 504 hours after start of treatment'}, {'measure': 'Predose concentration of the analytes in plasma at steady state immediately before administration of the next dose (Cpre,ss)', 'timeFrame': 'Pre-dose every 24 hours'}, {'measure': 'Time of last measurable concentration in plasma (tz)', 'timeFrame': 'up to 504 hours after start of treatment'}, {'measure': 'Linearity index (LI)', 'timeFrame': 'up to 504 hours after start of treatment'}, {'measure': 'Accumulation ratio based on Cmax (RA,Cmax)', 'timeFrame': 'up to 504 hours after start of treatment'}, {'measure': 'Accumulation ratio based on AUCτ (RA,AUC)', 'timeFrame': 'up to 504 hours after start of treatment'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 1744 CL and Tiotropium Bromide when given as fixed dose combination'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male based upon a complete medical history, including physical examination, regarding vital signs (BP, PR), 12-lead ECG measurement, and clinical laboratory tests. There is no finding deviating from normal and of clinical relevance. There is no evidence of a clinically relevant concomitant disease\n* Age ≥21 and ≤45 years\n* BMI ≥18.5 and \\<30 kg/m2 (Body Mass Index)\n* Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and the local legislation\n\nExclusion Criteria:\n\n* Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance\n* Evidence of a clinically relevant concomitant disease\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 relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator\n* Intake of drugs with a long half-life (\\>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to randomization\n* Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to randomisation\n* Participation in another trial with an investigational drug within 2 months prior to randomisation\n* Smoker (\\>10 cigarettes or \\>3 cigars or \\>3 pipes/day)\n* Inability to refrain from smoking on trial days as judged by the investigator\n* Alcohol abuse (more than 40 g alcohol a day)\n* Drug abuse\n* Blood donation (more than 100 mL blood within 4 weeks prior to randomisation or during the trial)\n* Excessive physical activities within 1 week prior to randomisation or during the trial\n* Any laboratory value outside the reference range that is of clinical relevance\n* Inability to comply with dietary regimen of the study centre\n\nThe following exclusion criteria are specific for this study due to the known class side effect profile of ß2-mimetics:\n\n* Asthma or history of pulmonary hyperreactivity\n* Hyperthyrosis\n* Allergic rhinitis in need of treatment\n* Clinically relevant cardiac arrhythmia\n* Paroxysmal tachycardia (\\>100 beats per minute)\n\nThe following exclusion criteria are specific for this study due to the known class side effect profile of Tiotropium:\n\n* Hypersensitivity to tiotropium and/or related drugs of these classes\n* History of narrow-angle glaucoma\n* History of prostatic hyperplasia\n* History of bladder-neck obstruction'}, 'identificationModule': {'nctId': 'NCT02259959', 'briefTitle': 'Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Inhalative Doses of BI 1744 CL in Fixed Dose Combination With Tiotropium Bromide in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Inhalative Doses (2 μg/5 μg, 10 μg/5 μg, and 40 μg/10 μg) of BI 1744 CL in Fixed Dose Combination With Tiotropium Bromide for 14 Days in Healthy Male Volunteers (Double-blind, Randomised, Placebo Controlled [at Each Dose Level] Study)', 'orgStudyIdInfo': {'id': '1237.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI 1744 CL in combination with Tiotropium', 'interventionNames': ['Drug: Single rising doses of BI 1744 CL, solution for oral inhalation', 'Drug: Tiotropium, fixed dose, solution for oral inhalation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Single rising doses of BI 1744 CL, solution for oral inhalation', 'type': 'DRUG', 'armGroupLabels': ['BI 1744 CL in combination with Tiotropium']}, {'name': 'Tiotropium, fixed dose, solution for oral inhalation', 'type': 'DRUG', 'armGroupLabels': ['BI 1744 CL in combination with Tiotropium']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}