Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT01687920
Status:
COMPLETED
Last Update Posted:
2022-02-07
First Post:
2012-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dose Proportionality Study With BAY94-8862 IR (Immediate Release) Tablets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C576501', 'term': 'finerenone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2013-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-27', 'studyFirstSubmitDate': '2012-09-14', 'studyFirstSubmitQcDate': '2012-09-14', 'lastUpdatePostDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose proportionality of BAY94-8862 exposure in plasma when given as 1.25, 2.5, 5.0, 7.5 and 10 mg IR tablets', 'timeFrame': '0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 28 & 48 h'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events as a measure of safety and tolerability of BAY94-8862', 'timeFrame': 'Up to 48 h'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiac disorders'], 'conditions': ['Heart Failure']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://clinicaltrials.bayer.com/', 'label': 'Click here to find results for studies related to Bayer products'}]}, 'descriptionModule': {'briefSummary': 'This study should estimate the dose proportionality of BAY94-8862 IR tablets.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '46 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subject\n* Age: 18 to 46 years (inclusive) at the first screening examination\n* Ethnicity: White\n* Body mass index (BMI): \\>= 18 and \\<= 29.9 kg / m²\n\nExclusion Criteria:\n\n* Clinically relevant findings in the ECG (electrocardiogram) such as a second- or third-degree AV block, prolongation of the QRS complex over 120 msec\n* Systolic blood pressure below 100 or above 140 mmHg\n* Diastolic blood pressure below 50 or above 90 mmHg\n* Heart rate below 50 or above 95 beats/ min\n* Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV 1+2)\n* Participation in another clinical study during the preceding 3 months (Last Treatment from previous study to First Treatment of new study)'}, 'identificationModule': {'nctId': 'NCT01687920', 'briefTitle': 'Dose Proportionality Study With BAY94-8862 IR (Immediate Release) Tablets', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Single Center, Randomized, Open-label, 5-fold Crossover Study in Healthy Male Subjects to Investigate the Pharmacokinetic Dose Proportionality of BAY94-8862 Given as 5 Different Single Oral IR Tablet Doses (1.25, 2.5, 5.0, 7.5 and 10 mg)', 'orgStudyIdInfo': {'id': '15481'}, 'secondaryIdInfos': [{'id': '2012-003055-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BAY94-8862 (1.25mg)', 'description': 'single dose BAY94-8862 IR tablet 1.25mg', 'interventionNames': ['Drug: BAY94-8862 (1.25mg)']}, {'type': 'EXPERIMENTAL', 'label': 'BAY94-8862 (2.5mg)', 'description': 'single dose BAY94-8862 IR tablet 2.5mg', 'interventionNames': ['Drug: BAY94-8862 (2.5mg)']}, {'type': 'EXPERIMENTAL', 'label': 'BAY94-8862 (5mg)', 'description': 'single dose BAY94-8862 IR tablet 5mg', 'interventionNames': ['Drug: BAY94-8862 (5mg)']}, {'type': 'EXPERIMENTAL', 'label': 'BAY94-8862 (7.5mg)', 'description': 'single dose BAY94-8862 IR tablet 7.5mg', 'interventionNames': ['Drug: BAY94-8862 (7.5mg)']}, {'type': 'EXPERIMENTAL', 'label': 'BAY94-8862 (10mg)', 'description': 'single dose BAY94-8862 IR tablet 10mg', 'interventionNames': ['Drug: BAY94-8862 (10mg)']}], 'interventions': [{'name': 'BAY94-8862 (1.25mg)', 'type': 'DRUG', 'armGroupLabels': ['BAY94-8862 (1.25mg)']}, {'name': 'BAY94-8862 (2.5mg)', 'type': 'DRUG', 'armGroupLabels': ['BAY94-8862 (2.5mg)']}, {'name': 'BAY94-8862 (5mg)', 'type': 'DRUG', 'armGroupLabels': ['BAY94-8862 (5mg)']}, {'name': 'BAY94-8862 (7.5mg)', 'type': 'DRUG', 'armGroupLabels': ['BAY94-8862 (7.5mg)']}, {'name': 'BAY94-8862 (10mg)', 'type': 'DRUG', 'armGroupLabels': ['BAY94-8862 (10mg)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41061', 'city': 'Mönchengladbach', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'CRS Clinical-Research-Services Mönchengladbach GmbH', 'geoPoint': {'lat': 51.18539, 'lon': 6.44172}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}