Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-02-21 @ 1:42 PM
Study NCT ID:
NCT03252002
Status:
COMPLETED
Last Update Posted:
2019-08-19
First Post:
2017-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of a Single and Multiple Oral BAY1101042 Tablet Doses in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-16', 'studyFirstSubmitDate': '2017-08-04', 'studyFirstSubmitQcDate': '2017-08-15', 'lastUpdatePostDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of treatment emergent adverse events (TEAEs)', 'timeFrame': 'Approximately 19 days', 'description': 'Assessment of treatment emergent adverse events from first study drug intake until follow up'}], 'secondaryOutcomes': [{'measure': 'AUC(0-24) of BAY1101042', 'timeFrame': 'At day 1', 'description': 'AUC(0-24): area under the concentration vs. time curve from zero to 24 hours after single dose'}, {'measure': 'AUC(0-24)/D of BAY1101042', 'timeFrame': 'At day 1', 'description': 'AUC(0-24)/D: dose-normalized area under the concentration vs. time curve from zero to 24 hours after single dose'}, {'measure': 'Cmax of BAY1101042', 'timeFrame': 'At day 1', 'description': 'Cmax: maximum observed drug concentration after single dose'}, {'measure': 'Cmax/D of BAY1101042', 'timeFrame': 'At day 1', 'description': 'Cmax/D: dose-normalized maximum observed drug concentration after single dose'}, {'measure': 'AUCτ,md of BAY1101042', 'timeFrame': 'At day 9', 'description': 'AUCτ,md: area under the concentration vs. time curve for the actual dosing interval after multiple dose'}, {'measure': 'AUCτ,md/D of BAY1101042', 'timeFrame': 'At day 9', 'description': 'AUCτ,md/D: dose-normalized area under the concentration vs. time curve for the actual dosing interval after multiple dose'}, {'measure': 'Cmax,md of BAY1101042', 'timeFrame': 'At day 9', 'description': 'Cmax,md: maximum observed drug concentration after multiple dose'}, {'measure': 'Cmax,md/D of BAY1101042', 'timeFrame': 'At day 9', 'description': 'Cmax,md/D: dose-normalized maximum observed drug concentration after multiple dose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic kidney disease'], 'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'To investigate the safety, tolerability, pharmacokinetics and effects of BAY1101042 in healthy male subjects after a single oral dose and multiple once daily dosing for 7 days'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The informed consent must be signed before any study specific tests or procedures are done.\n* Healthy male subject.\n* Age: 18 to 45 years (inclusive) at the screening.\n* Body mass index (BMI): above/equal 18 and below/equal 29.9 kg/m2.\n* Ability to understand and follow study-related instructions.\n\nExclusion Criteria:\n\n* Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.\n* Subjects with thyroid disorders as evidenced by assessment of thyroid stimulating hormone (TSH) levels outside the normal reference range at screening.\n* Regular use of medicines.\n* Smoking more than 10 cigarettes daily.\n* Systolic blood pressure below 100 or above 145 mmHg (at screening).\n* Diastolic blood pressure below 50 or above 90 mmHg (at screening).\n* Heart rate below 50 or above 90 beats/ min (at screening).'}, 'identificationModule': {'nctId': 'NCT03252002', 'briefTitle': 'Clinical Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of a Single and Multiple Oral BAY1101042 Tablet Doses in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Single/Multiple Dose Escalation Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BAY1101042 Given as 5 mg MR Tablet After Single Oral Dosing Followed by Once Daily Dosing for 7 Days in 12 Healthy Male Subjects Per Dose Step in a Randomized, Placebo Controlled, Single Blind, Group Comparison Design', 'orgStudyIdInfo': {'id': '18747'}, 'secondaryIdInfos': [{'id': '2017-001212-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single/multiple doses of 10 mg BAY1101042 or placebo', 'description': 'Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days', 'interventionNames': ['Drug: BAY1101042', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Single/ multiple doses of 20 mg BAY1101042 or placebo', 'description': 'Single oral dose of 20 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days', 'interventionNames': ['Drug: BAY1101042', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Single/ multiple doses of 30 mg BAY1101042 or placebo', 'description': 'Single oral dose of 30 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days', 'interventionNames': ['Drug: BAY1101042', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Single/ multiple doses of 40 mg BAY1101042 or placebo', 'description': 'Single oral dose of 40 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days', 'interventionNames': ['Drug: BAY1101042', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Single/ multiple doses of 50 mg BAY1101042 or placebo', 'description': 'Single oral dose of 50 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days', 'interventionNames': ['Drug: BAY1101042', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Optional: Single/multiple doses of 5 mg BAY 1101042 or placebo', 'description': 'Single oral dose of 5 mg BAY1101042 MR tablets or corresponding placebo followed by once daily dosing for 7 days', 'interventionNames': ['Drug: BAY1101042', 'Drug: Placebo']}], 'interventions': [{'name': 'BAY1101042', 'type': 'DRUG', 'description': 'Single oral dose of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg or optionally 5 mg BAY 1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days', 'armGroupLabels': ['Optional: Single/multiple doses of 5 mg BAY 1101042 or placebo', 'Single/ multiple doses of 20 mg BAY1101042 or placebo', 'Single/ multiple doses of 30 mg BAY1101042 or placebo', 'Single/ multiple doses of 40 mg BAY1101042 or placebo', 'Single/ multiple doses of 50 mg BAY1101042 or placebo', 'Single/multiple doses of 10 mg BAY1101042 or placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Single dose on Day 1 (00d) and once daily for 7 days from Day 3 (02d) until Day 9 (08d)', 'armGroupLabels': ['Optional: Single/multiple doses of 5 mg BAY 1101042 or placebo', 'Single/ multiple doses of 20 mg BAY1101042 or placebo', 'Single/ multiple doses of 30 mg BAY1101042 or placebo', 'Single/ multiple doses of 40 mg BAY1101042 or placebo', 'Single/ multiple doses of 50 mg BAY1101042 or placebo', 'Single/multiple doses of 10 mg BAY1101042 or placebo']}]}, '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}}, {'zip': '42113', 'city': 'Wuppertal', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'CRS Clinical Research Services Wuppertal GmbH', 'geoPoint': {'lat': 51.25627, 'lon': 7.14816}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}