Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-26 @ 1:20 PM
Study NCT ID:
NCT02171767
Status:
COMPLETED
Last Update Posted:
2014-06-24
First Post:
2014-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of 4 Different Dosage Strengths of BIBW 2992 Tablets to Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'lastUpdateSubmitDate': '2014-06-20', 'studyFirstSubmitDate': '2014-06-20', 'studyFirstSubmitQcDate': '2014-06-20', 'lastUpdatePostDateStruct': {'date': '2014-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax (maximum measured concentration of the analyte in plasma)', 'timeFrame': 'predose, up to120 h 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 time of the last quantifiable data point)', 'timeFrame': 'predose, up to 120 h 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': 'predose, up to 120 h after drug administration'}], 'secondaryOutcomes': [{'measure': '%AUCtz-∞ (percentage of the AUCtz-∞ obtained by extrapolation from the last quantifiable data point to infinity)', 'timeFrame': 'predose, up to 120 h after drug administration'}, {'measure': 'AUC0-24 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 [predose] to 24 h)', 'timeFrame': 'predose, up to 120 h after drug administration'}, {'measure': 'tmax (time from dosing to the maximum concentration of the analyte in plasma)', 'timeFrame': 'predose, up to 120 h after drug administration'}, {'measure': 'λz (terminal rate constant of the analyte in plasma)', 'timeFrame': 'predose, up to 120 h after drug administration'}, {'measure': 't1/2 (terminal half-life of the analyte in plasma)', 'timeFrame': 'predose, up to 120 h days after drug administration'}, {'measure': 'MRTpo (mean residence time of the analyte in the body after oral administration)', 'timeFrame': 'predose, up to 120 h after drug administration'}, {'measure': 'CL/F (apparent clearance of the analyte in plasma after extravascular administration)', 'timeFrame': 'predose, up to 120 h after drug administration'}, {'measure': 'Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)', 'timeFrame': 'predose, up to 120 h after drug administration'}, {'measure': 'Number of patients with abnormal findings in physical examination', 'timeFrame': 'Screening, up to 20 days after drug administration'}, {'measure': 'Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate)', 'timeFrame': 'Screening, up to 20 days after drug administration'}, {'measure': 'Number of patients with abnormal changes in laboratory parameters', 'timeFrame': 'Screening, up to 20 days after drug administration'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'up to 41 days'}, {'measure': 'Assessment of tolerability by investigator on a 4-point scale', 'timeFrame': 'up to 20 days after drug administration'}, {'measure': 'Number of patients with abnormal changes in 12-lead electrocardiogram (ECG)', 'timeFrame': 'Screening, up to 20 days after drug administration'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Study to assess pharmacokinetics incl. dose proportionality, safety and tolerability of 4 different dosage strengths of BIBW 2992 tablets (final formulation of 20 mg, 30 mg, 40 mg, 50 mg) administered as single doses to healthy male volunteers'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males according to a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead Electrocardiogram (ECG), and clinical laboratory tests\n* Age 21 to 55 years, inclusive\n* Body mass index 18.5 to 29.9 kg/m2, inclusive\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 Blood Pressure (BP), Puse Rate (PR) and Electrocardiogram (ECG)) deviating from normal and of clinical relevance\n* Any evidence of a clinically relevant concomitant disease\n* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n* Surgery of the gastrointestinal tract (except appendectomy)\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 drug allergy or its excipients)\n* Intake of drugs with a long half-life (\\>24 hours) within 1 month prior to administration of the trial drug or during the trial\n* Use of any drugs (including herbal preparations, vitamins and nutrient supplements) within 10 days prior to administration of the trial drug or during the trial\n* Participation in another trial with an investigational drug within 2 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 within the in-house periods from 12 hours before until 25 hours after each administration of the trial drug\n* Alcohol abuse (more than 30 g/day)\n* Drug abuse\n* Blood donation (more than 100 mL within 4 weeks prior to administration of the trial drug or during the trial)\n* Excessive physical activities (within 1 week prior to administration of the trial drug 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 trial site\n* A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \\>450 ms)\n* A history of additional risk factors for Torsades de Points, e.g., heart failure, hypokalemia, family history of Long QT Syndrome\n\nExclusion criteria specific for this study:\n\n* History of clinically relevant skin diseases, psoriasis or moderate/severe acne\n* History or evidence of interstitial lung disease\n* Males who are unwilling to use a medically acceptable method of contraception during the first 3 months after administration of the trial drug. Acceptable methods of contraception for use by male volunteers include sexual abstinence, a vasectomy performed at least 1 year prior to dosing, barrier contraception or another medically accepted contraceptive method'}, 'identificationModule': {'nctId': 'NCT02171767', 'briefTitle': 'Safety and Tolerability of 4 Different Dosage Strengths of BIBW 2992 Tablets to Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Pharmacokinetics, Safety and Tolerability of BIBW 2992 Administered Orally as 20 mg, 30 mg, 40 mg, and 50 mg Tablets (Final Formulation) to Healthy Male Volunteers in an Open-label, Single Rising Dose, Phase I Trial', 'orgStudyIdInfo': {'id': '1200.80'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIBW 2992 MA2 - single rising dose', 'interventionNames': ['Drug: BIBW 2992 MA2 - single rising dose']}], 'interventions': [{'name': 'BIBW 2992 MA2 - single rising dose', 'type': 'DRUG', 'armGroupLabels': ['BIBW 2992 MA2 - single rising dose']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}