Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-01-05 @ 11:33 PM
Study NCT ID:
NCT06327256
Status:
COMPLETED
Last Update Posted:
2024-11-13
First Post:
2024-03-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study in Healthy People to Test How Well Different Doses of BI 3000202 Are Tolerated and How They Affect the Way the Body Handles Midazolam
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}], '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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'The multiple rising dose part of the trial will be blinded to the participants and investigators . The effect of midazolam will be assessed open label.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'The multiple rising dose part of the trial will be conducted in a parallel group assignment. The effect of midazolam interaction will be assessed sequentially.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-12', 'studyFirstSubmitDate': '2024-03-18', 'studyFirstSubmitQcDate': '2024-03-18', 'lastUpdatePostDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of subjects with drug-related adverse events', 'timeFrame': 'Up to day 20'}], 'secondaryOutcomes': [{'measure': 'Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to 12 hours (AUC0-12)', 'timeFrame': 'Up to 12 hours'}, {'measure': 'Maximum measured concentration BI 3000202 in plasma (Cmax)', 'timeFrame': 'Up to 24 hours'}, {'measure': 'Area under the concentration-time curve of BI 3000202 in plasma over a uniform dosing interval τ (AUCτ,ss) at steady state', 'timeFrame': 'Up to day 20'}, {'measure': 'Maximum measured concentration of BI 3000202 in plasma (Cmax,ss) at steady state', 'timeFrame': 'Up to day 20'}, {'measure': 'Time from dosing to the maximum measured concentration of BI 3000202 in plasma (tmax,ss) at steady state', 'timeFrame': 'Up to day 20'}, {'measure': 'Area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) after a single dose', 'timeFrame': 'Up to 2 days'}, {'measure': 'Maximum measured concentration of midazolam in plasma (Cmax) after a single dose', 'timeFrame': 'Up to 2 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) following multiple rising doses of BI 3000202 and to investigate the effect of BI 3000202 on the metabolism of midazolam.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or female of non-childbearing potential subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests\n* Age of 18 to 55 years (inclusive)\n* Body mass index (BMI) of 18.5 to 29.9 kg/m\\^2 (inclusive)\n* Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial\n\nExclusion Criteria:\n\n* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator\n* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm\n* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance\n* Any evidence of a concomitant disease assessed as clinically relevant by the investigator\n* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)\n* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders\n* History of relevant orthostatic hypotension, fainting spells, or blackouts\n* Further exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT06327256', 'briefTitle': 'A Study in Healthy People to Test How Well Different Doses of BI 3000202 Are Tolerated and How They Affect the Way the Body Handles Midazolam', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 3000202 in Healthy Male and Female Subjects (Double-blind, Randomised, Placebo-controlled, Parallel Group Design) and Evaluation of Midazolam Interaction in Healthy Male and Female Subjects (Nested, Open, Fixed-sequence, Intra-individual Comparison)', 'orgStudyIdInfo': {'id': '1509-0002'}, 'secondaryIdInfos': [{'id': '2023-509293-29-00', 'type': 'REGISTRY', 'domain': 'CTIS'}, {'id': 'U1111-1299-6907', 'type': 'REGISTRY', 'domain': 'WHO International Clinical Trials Registry Platform (ICTRP)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose group 1', 'description': 'Group receiving placebo or dose 1 of BI 3000202', 'interventionNames': ['Drug: BI 3000202', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Dose group 2', 'description': 'Group receiving placebo or dose 2 of BI 3000202', 'interventionNames': ['Drug: BI 3000202', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Dose group 3', 'description': 'Group receiving midazolam, midazolam and dose 3 of BI 3000202 or midazolam and placebo, and only BI 3000202 or only placebo', 'interventionNames': ['Drug: BI 3000202', 'Drug: Placebo', 'Drug: Midazolam']}, {'type': 'EXPERIMENTAL', 'label': 'Dose group 4', 'description': 'Group receiving midazolam, midazolam and dose 4 of BI 3000202 or midazolam and placebo, and only BI 3000202 or only placebo', 'interventionNames': ['Drug: BI 3000202', 'Drug: Placebo', 'Drug: Midazolam']}], 'interventions': [{'name': 'BI 3000202', 'type': 'DRUG', 'description': 'BI 3000202', 'armGroupLabels': ['Dose group 1', 'Dose group 2', 'Dose group 3', 'Dose group 4']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo-matching BI 3000202', 'armGroupLabels': ['Dose group 1', 'Dose group 2', 'Dose group 3', 'Dose group 4']}, {'name': 'Midazolam', 'type': 'DRUG', 'description': 'Midazolam', 'armGroupLabels': ['Dose group 3', 'Dose group 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'SGS Life Science Services - Clinical Research', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}