Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-01-08 @ 3:44 AM
Study NCT ID:
NCT02199860
Status:
COMPLETED
Last Update Posted:
2014-07-25
First Post:
2014-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Rising Dose Study Investigating the Safety, Tolerability and Pharmacokinetics of Spray Dried BIBN 4096 BS After Inhalation Administration in Healthy Male and Female 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': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'lastUpdateSubmitDate': '2014-07-24', 'studyFirstSubmitDate': '2014-07-24', 'studyFirstSubmitQcDate': '2014-07-24', 'lastUpdatePostDateStruct': {'date': '2014-07-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with adverse events', 'timeFrame': 'up to 25 days'}, {'measure': 'Assessment of tolerability on a 4-point scale', 'timeFrame': '8 days after drug administration'}, {'measure': 'Change in lung function measurements airway resistance (Raw)', 'timeFrame': 'up to 5 hours after drug administration'}, {'measure': 'Change in lung function measurement specific conductance (SGaw)', 'timeFrame': 'up to 5 hours after drug administration'}, {'measure': 'Change in lunf function measurement forced expiratory volume in 1 second (FEV1)', 'timeFrame': 'up to 5 hours after drug administration'}], 'secondaryOutcomes': [{'measure': 'Cmax (Maximum measured concentration of the analyte in plasma)', 'timeFrame': 'up to 48 hours after drug administration'}, {'measure': 'tmax (Time from dosing to the maximum concentration of the analyte in plasma)', 'timeFrame': 'up to 48 hours after drug administration'}, {'measure': 'AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)', 'timeFrame': 'up to 48 hours after drug administration'}, {'measure': 'AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)', 'timeFrame': 'up to 48 hours after drug administration'}, {'measure': 'λz (Terminal rate constant in plasma)', 'timeFrame': 'up to 48 hours after drug administration'}, {'measure': 't½ (Terminal half-life of the analyte in plasma)', 'timeFrame': 'up to 48 hours after drug administration'}, {'measure': 'MRTih (Mean residence time of the analyte in the body after inhalation)', 'timeFrame': 'up to 48 hours after drug administration'}, {'measure': 'CL/F (Apparent clearance of the analyte in plasma following extravascular administration)', 'timeFrame': 'up to 48 hours after drug administration'}, {'measure': 'Vz/F (Apparent volume of distribution of the analyte during the terminal phase)', 'timeFrame': 'up to 48 hours after drug administration'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of the present study was to obtain information about the safety, tolerability and pharmacokinetics of BIBN 4096 BS after single inhalation administration of rising doses of spray-dried powder in healthy male and female volunteers. According to the original protocol, the primary objective was to investigate the safety and tolerability of single doses of a new spray-dried inhalation formulation of BIBN 4096 BS (SD I). Following implementation of Amendment 2, this objective was extended to the second spray-dried inhalation formulation SD II with and without concomitant administration of lactose'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects could be included in the study if they met the following criteria:\n\n* Healthy male or female volunteers\n* Written informed consent in accordance with Good Clinical Practice (GCP) and the local legislation prior to admission to the study\n* Age 21 - 50 years\n* Body mass index (BMI): 18.5 - 29.9 kg/m2\n\nExclusion Criteria:\n\nSubjects were not allowed to participate if any of the following applied:\n\n* Any finding of the medical examination (including blood pressure, pulse rate, Respiratory rate, body temperature and ECG) deviating from normal and of clinical relevance\n* Raw \\> 3 cm H2O • s • L-1 or FEV1 \\<80% of predicted\n* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n* Diseases of the central nervous system, 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 was deemed relevant to the trial as judged 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 before enrolment in the study\n* Use of any drugs which might influence the results of the trial (within 1 week prior to administration of investigational drug or during the trial)\n* Participation in another trial with an investigational drug (within 2 months prior to drug administration or during the trial)\n* Smoker (\\>10 cigarettes/day or \\>3 cigars/day or \\>3 pipes/day)\n* Inability to refrain from smoking on trial days\n* Alcohol abuse (\\>60 gram/day)\n* Drug abuse\n* Blood donation (≥100 mL within 4 weeks prior to administration of investigational drug or during the trial)\n* Excessive physical activities (within the last week before the study)\n* Any laboratory value outside the reference range and of clinical relevance\n* For female subjects:\n\n * Pregnancy\n * Positive pregnancy test\n * No adequate contraception e.g. oral contraceptives, sterilization, intrauterine device\n * Inability to maintain this adequate contraception during the whole study period,\n * Lactation period'}, 'identificationModule': {'nctId': 'NCT02199860', 'briefTitle': 'Single Rising Dose Study Investigating the Safety, Tolerability and Pharmacokinetics of Spray Dried BIBN 4096 BS After Inhalation Administration in Healthy Male and Female Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Double-blind (at Each Dose Level), Randomised, Placebo-controlled, Single Rising Dose Study Investigating the Safety, Tolerability and Pharmacokinetics of Two Spray-dried Formulations of BIBN 4096 BS After Inhalation Administration in Healthy Male and Female Volunteers', 'orgStudyIdInfo': {'id': '1149.44'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SD I - single rising doses', 'interventionNames': ['Drug: SD I']}, {'type': 'EXPERIMENTAL', 'label': 'SD II - single rising doses', 'interventionNames': ['Drug: SD II']}, {'type': 'EXPERIMENTAL', 'label': 'SD II - single rising doses + Placebo', 'interventionNames': ['Drug: SD II', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SD I', 'type': 'DRUG', 'armGroupLabels': ['SD I - single rising doses']}, {'name': 'SD II', 'type': 'DRUG', 'armGroupLabels': ['SD II - single rising doses', 'SD II - single rising doses + Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo', 'SD II - single rising doses + Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}