Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-01 @ 5:35 PM
Study NCT ID:
NCT06166992
Status:
COMPLETED
Last Update Posted:
2025-08-13
First Post:
2023-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study in Healthy Men to Test How BI 1291583 is Taken up by the Body
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2023-12-04', 'studyFirstSubmitQcDate': '2023-12-04', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity (AUC0-∞)', 'timeFrame': 'Up to 10 days'}], 'secondaryOutcomes': [{'measure': 'Maximum measured concentration of the analyte in plasma (Cmax)', 'timeFrame': 'Up to 10 days'}, {'measure': 'Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz)', 'timeFrame': 'Up to 10 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this trial is to investigate the absolute bioavailability of BI 1291583 (test treatment T, not radio-labelled) compared with BI 1291583 (C-14) (reference treatment R).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy male 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\n2. Age of 18 to 55 years (inclusive)\n3. Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)\n4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.\n\nExclusion Criteria:\n\n1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator\n2. 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\n3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance\n4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator\n5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)\n7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders\n8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT06166992', 'briefTitle': 'A Study in Healthy Men to Test How BI 1291583 is Taken up by the Body', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Investigation of Pharmacokinetics and Absolute Oral Bioavailability of BI 1291583 Administered as an Oral Dose With an Intravenous Microtracer Dose of [14C]-BI 1291583 in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': '1397-0026'}, 'secondaryIdInfos': [{'id': '2023-505683-11-00', 'type': 'REGISTRY', 'domain': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI 1291583 alone (not radio-labelled, low dose) then [14C]-BI 1291583 (radio-labelled)', 'interventionNames': ['Drug: BI 1291583', 'Drug: [14C]-BI 1291583']}, {'type': 'EXPERIMENTAL', 'label': 'BI 1291583 alone (not radio-labelled, high dose) then [14C]-BI 1291583 (radio-labelled)', 'interventionNames': ['Drug: BI 1291583', 'Drug: [14C]-BI 1291583']}], 'interventions': [{'name': 'BI 1291583', 'type': 'DRUG', 'otherNames': ['Verducatib'], 'description': 'BI 1291583', 'armGroupLabels': ['BI 1291583 alone (not radio-labelled, high dose) then [14C]-BI 1291583 (radio-labelled)', 'BI 1291583 alone (not radio-labelled, low dose) then [14C]-BI 1291583 (radio-labelled)']}, {'name': '[14C]-BI 1291583', 'type': 'DRUG', 'otherNames': ['Verducatib'], 'description': '\\[14C\\]-BI 1291583', 'armGroupLabels': ['BI 1291583 alone (not radio-labelled, high dose) then [14C]-BI 1291583 (radio-labelled)', 'BI 1291583 alone (not radio-labelled, low dose) then [14C]-BI 1291583 (radio-labelled)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9728 NZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'ICON', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}]}, '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).\n\nFor more details refer to:\n\nhttps://www.mystudywindow.com/msw/datatransparency'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}