Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-01-18 @ 1:39 PM
Study NCT ID:
NCT02183493
Status:
COMPLETED
Last Update Posted:
2014-07-08
First Post:
2014-07-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability of BI 1356 Administered With and Without Food to Healthy Male and Female Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069476', 'term': 'Linagliptin'}], 'ancestors': [{'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011799', 'term': 'Quinazolines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'lastUpdateSubmitDate': '2014-07-04', 'studyFirstSubmitDate': '2014-07-04', 'studyFirstSubmitQcDate': '2014-07-04', 'lastUpdatePostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the concentration-time curve of BI 1356 in plasma over the time interval from 0 to 72 h (AUC0-72)', 'timeFrame': 'up to 72 hours after start of treatment'}, {'measure': 'Maximum measured concentration (Cmax) of BI 1356 in plasma', 'timeFrame': 'up to 96 hours after start of treatment'}], 'secondaryOutcomes': [{'measure': 'Area under the concentration-time curve of BI 1356 in plasma at different time points', 'timeFrame': 'up to 96 hours after start of treatment'}, {'measure': 'Time from dosing to the maximum concentration (tmax) of BI 1356 in plasma', 'timeFrame': 'up to 96 hours after start of treatment'}, {'measure': 'Terminal elimination rate constant (λz) in plasma', 'timeFrame': 'up to 96 hours after start of treatment'}, {'measure': 'Terminal half-life (t1/2) of BI 1356 in plasma', 'timeFrame': 'up to 96 hours after start of treatment'}, {'measure': 'Mean residence time of BI 1356 in the body after oral administration (MRTpo)', 'timeFrame': 'up to 96 hours after start of treatment'}, {'measure': 'Apparent clearance of BI 1356 in the plasma after extravascular administration (CL/F)', 'timeFrame': 'up to 96 hours after start of treatment'}, {'measure': 'Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)', 'timeFrame': 'up to 96 hours after start of treatment'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'up to 11 weeks'}, {'measure': 'Assessment of tolerability on a 4-point scale by investigator', 'timeFrame': '14 days after last study drug administration'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To investigate the food effect on the relative bioavailability and pharmacokinetics of a 5 mg BI 1356 tablet administered as a single dose'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males and females according to the following criteria:\n\n \\-- Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests\n* Age ≥ 18 and Age ≤ 50 years\n* BMI ≥ 18.5 and BMI ≤ 29.9 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 deviating from normal and of clinical relevance. Repeated measurement of a systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg\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 allergy to drug or its excipients)\n* Intake of drugs within one month or less than 10 half-lives of the respective drug prior to first study drug administration and during the trial except if a relevant interaction can be ruled out\n* Participation in another trial with an investigational drug within two months prior to first study drug 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 (average consumption of more than 20 g/day in females and 30 g/day in males)\n* Drug abuse\n* Blood donation (more than 100 mL within four weeks prior to the start of study)\n* Excessive physical activities (within one week prior to administration 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\nFor female subjects:\n\n* Positive pregnancy test, pregnancy or planning to become pregnant during the study or within 2 months after study completion\n* No adequate contraception during the study and until 2 months after study completion, i.e. not any of the following: implants, injectables, combined oral contraceptives, intrauterine device (IUD) , sexual abstinence for at least 1 month prior to enrolment, vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (including hysterectomy). Females, who do not have a vasectomised partner, are not sexually abstinent or surgically sterile will be asked to use an additional barrier method (e.g. condom, diaphragm with spermicide)\n* Lactation'}, 'identificationModule': {'nctId': 'NCT02183493', 'briefTitle': 'Bioavailability of BI 1356 Administered With and Without Food to Healthy Male and Female Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Relative Bioavailability of a 5 mg BI 1356 Tablet Administered With and Without Food to Healthy Male and Female Subjects in an Open, Randomised, Single Dose, Two-way Crossover, Phase I Trial', 'orgStudyIdInfo': {'id': '1218.34'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fed administration of BI 1356', 'interventionNames': ['Drug: BI 1356']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fasted administration of BI 1356', 'interventionNames': ['Drug: BI 1356']}], 'interventions': [{'name': 'BI 1356', 'type': 'DRUG', 'armGroupLabels': ['Fasted administration of BI 1356', 'Fed administration of BI 1356']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}