Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-01-02 @ 12:45 PM
Study NCT ID:
NCT06772532
Status:
COMPLETED
Last Update Posted:
2025-07-08
First Post:
2025-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study in Healthy People to Compare How 3 Different Formulations of Survodutide Are Taken up in the Body
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-07', 'studyFirstSubmitDate': '2025-01-10', 'studyFirstSubmitQcDate': '2025-01-10', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)', 'timeFrame': 'Up to 22 days'}, {'measure': 'Maximum measured concentration of the analyte in plasma (Cmax)', 'timeFrame': 'Up to 22 days'}], 'secondaryOutcomes': [{'measure': 'Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)', 'timeFrame': 'Up to 22 days'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, '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 relative bioavailability of BI 456906 formulation B and BI 456906 formulation C vs. BI 456906 formulation A.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or female 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 20 to 29.9 kg/m² (inclusive)\n* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.\n\nFurther inclusion criteria apply.\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 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (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\nFurther exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT06772532', 'briefTitle': 'A Study in Healthy People to Compare How 3 Different Formulations of Survodutide Are Taken up in the Body', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Relative Bioavailability of Three Different BI 456906 Formulations Following Subcutaneous Administration in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Three-period, Three-sequence Crossover Trial)', 'orgStudyIdInfo': {'id': '1404-0074'}, 'secondaryIdInfos': [{'id': '2024-516529-30-00', 'type': 'REGISTRY', 'domain': 'CTIS'}, {'id': 'U1111-1310-7283', 'type': 'REGISTRY', 'domain': 'WHO International Clinical Trials Registry Platform (ICTRP)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment sequence R-T2-T1', 'description': 'T1: BI 456906 formulation B T2: BI 456906 formulation C R: BI 456906 formulation A', 'interventionNames': ['Drug: BI 456906 - Formulation A', 'Drug: BI 456906 - Formulation B', 'Drug: BI 456906 - Formulation C']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment sequence T1-R-T2', 'interventionNames': ['Drug: BI 456906 - Formulation A', 'Drug: BI 456906 - Formulation B', 'Drug: BI 456906 - Formulation C']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment sequence T2-T1-R', 'interventionNames': ['Drug: BI 456906 - Formulation A', 'Drug: BI 456906 - Formulation B', 'Drug: BI 456906 - Formulation C']}], 'interventions': [{'name': 'BI 456906 - Formulation A', 'type': 'DRUG', 'otherNames': ['Survodutide'], 'description': 'Formulation A', 'armGroupLabels': ['Treatment sequence R-T2-T1', 'Treatment sequence T1-R-T2', 'Treatment sequence T2-T1-R']}, {'name': 'BI 456906 - Formulation B', 'type': 'DRUG', 'otherNames': ['Survodutide'], 'description': 'Formulation B', 'armGroupLabels': ['Treatment sequence R-T2-T1', 'Treatment sequence T1-R-T2', 'Treatment sequence T2-T1-R']}, {'name': 'BI 456906 - Formulation C', 'type': 'DRUG', 'otherNames': ['Survodutide'], 'description': 'Formulation C', 'armGroupLabels': ['Treatment sequence R-T2-T1', 'Treatment sequence T1-R-T2', 'Treatment sequence T2-T1-R']}]}, 'contactsLocationsModule': {'locations': [{'zip': '88397', 'city': 'Biberach/Riß', 'country': 'Germany', 'facility': 'Humanpharmakologisches Zentrum Biberach'}]}, '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'}}}}