Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-29 @ 5:21 PM
Study NCT ID:
NCT04447261
Status:
COMPLETED
Last Update Posted:
2021-05-19
First Post:
2020-06-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Test How Well Different Doses of BI 1356225 Are Tolerated by Men and Women With Obesity or Overweight
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-18', 'studyFirstSubmitDate': '2020-06-24', 'studyFirstSubmitQcDate': '2020-06-24', 'lastUpdatePostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of subjects with drug-related adverse events', 'timeFrame': 'Up to 40 days'}], 'secondaryOutcomes': [{'measure': 'AUCτ, 1 (area under the concentration-time curve of BI 1356225 in plasma over a uniform dosing interval τ after administration of the first dose)', 'timeFrame': 'Up to 35 days'}, {'measure': 'Cmax,1 (maximum measured concentration of BI 1356225 in plasma after administration of the first dose)', 'timeFrame': 'Up to 35 days'}, {'measure': 'AUCτ,ss (area under the concentration-time curve of BI 1356225 in plasma at steady state over a uniform dosing interval τ after administration of the last dose)', 'timeFrame': 'Up to 35 days'}, {'measure': 'Cmax,ss (maximum measured concentration of BI 1356225 in plasma at steady state over a uniform dosing interval τ after administration of the last dose)', 'timeFrame': 'Up to 35 days'}, {'measure': 'AUC0-tz (area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point)', 'timeFrame': 'Up to 35 days'}, {'measure': 'AUC0-tz (area under the concentration-time curve of celecoxib in plasma over the time interval from 0 to the last quantifiable data point)', 'timeFrame': 'Up to 35 days'}, {'measure': 'Cmax (maximum measured concentration of midazolam in plasma)', 'timeFrame': 'Up to 35 days'}, {'measure': 'Cmax (maximum measured concentration of celecoxib in plasma)', 'timeFrame': 'Up to 35 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this trial is to investigate safety and tolerability of BI 1356225 in male and female patients with overweight and obesity following oral administration of multiple rising doses per day over 28 days. Secondary objectives are the exploration of pharmacokinetics (PK) of BI 1356225 after multiple oral dosing. Additionally, the relative bioavailability (BA) of midazolam and celecoxib in the presence and absence of BI 1356225 will be evaluated'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Male and female patients, age ≥ 18 and \\< 70\n* Body Mass Index ≥ 27 kg/m2 and \\< 40 kg/m2 at screening\n* Stable body weight (defined as no more than 5% change) within 3 months prior to screening\n* further inclusion criteria apply\n\nExclusion criteria\n\n* Females of childbearing potential\n* Clinically relevant concomitant disease per investigator judgment\n* Any condition or disease requiring permanent pharmacotherapy during the trial\n* Any history of lifetime suicidal behaviour and any suicidal ideation of type 2 - 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS) in the past 12 months\n* further exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT04447261', 'briefTitle': 'A Study to Test How Well Different Doses of BI 1356225 Are Tolerated by Men and Women With Obesity or Overweight', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 1356225 (Randomised, Placebo-controlled, Blinded Within Dose Groups) and Evaluation of Midazolam and Celecoxib Interaction (Nested, Open, Fixed-sequence, Intra-individual Comparison) in Patients With Overweight or Obesity', 'orgStudyIdInfo': {'id': '1427-0002'}, 'secondaryIdInfos': [{'id': '2020-000342-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI 1356225', 'interventionNames': ['Drug: BI 1356225']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BI 1356225', 'type': 'DRUG', 'description': 'BI 1356225', 'armGroupLabels': ['BI 1356225']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68167', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'CRS Clinical Research Services Mannheim GmbH', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}]}, '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, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).For more details refer to: http://trials.boehringer-ingelheim.com/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}