Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT03493269
Status:
COMPLETED
Last Update Posted:
2021-02-26
First Post:
2018-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multiple Dose Study of BAY1834845 in Healthy Male Subjects and in Patients With Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723917', 'term': 'zabedosertib'}, {'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double blind'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-25', 'studyFirstSubmitDate': '2018-04-04', 'studyFirstSubmitQcDate': '2018-04-04', 'lastUpdatePostDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Approximately 47 days', 'description': 'Part 1 in healthy male subject'}, {'measure': 'Severity of treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Approximately 47 days', 'description': 'Part 1 in healthy male subject'}, {'measure': 'Frequency of treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Approximately 84 days', 'description': 'Part 2: Patients with psoriasis'}, {'measure': 'Severity of treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Approximately 84 days', 'description': 'Part 2: Patients with psoriasis'}, {'measure': 'AUC(0-24)md of BAY1834845', 'timeFrame': 'Part 1 - Period 1 (dose group 1-4): Day 1 to 2 Part 1 - Period 2 (dose group 5): Day 1 to 2', 'description': 'Part 1 AUC(0-24)md: AUC from zero to 24 hours after multiple dosing'}, {'measure': 'AUC(0-12)md of BAY1834845', 'timeFrame': 'Part 1 - Period 1 (dose group 1-4): Day 1, Part 1 - Period 2 (dose group 5): Day 1', 'description': 'Part 1 AUC(0-12)md:AUC from zero to 12 hours after multiple dosing'}, {'measure': 'Cmax,md of BAY1834845', 'timeFrame': 'Part 1 - Period 1 (dose group 1-4): Day 1, Part 1 - Period 2 (dose group 5): Day 1', 'description': 'Part 1 Cmax,md:Cmax(Maximum observed drug concentration, directly taken from analytical data) after multiple dosing'}, {'measure': 'Cav,md of BAY1834845', 'timeFrame': 'Part 1 - Period 1 (dose group 1-4): Day 1 to 2 Part 1 - Period 2 (dose group 5): Day 1 to 2', 'description': 'Part 1 Cav:Average concentration within a dosing interval after multiple dosing'}, {'measure': 'AUC(0-24)md of BAY1834845', 'timeFrame': 'Part 2: one day between day 35 and 42', 'description': 'Part 2: AUC(0-24)md: AUC from zero to 24 hours after multiple dosing'}, {'measure': 'AUC(0-12)md of BAY1834845', 'timeFrame': 'Part 2: one day between day 35 and 42', 'description': 'Part 2: AUC(0-12)md: AUC from zero to 12 hours after multiple dosing'}, {'measure': 'Cmax,md of BAY1834845', 'timeFrame': 'Part 2: one day between day 35 and 42', 'description': 'Part 2: Cmax,md:Cmax (Maximum observed drug concentration, directly taken from analytical data) after multiple dosing'}, {'measure': 'Cav, md of BAY1834845', 'timeFrame': 'Part 2: one day between day 35 and 42', 'description': 'Part 2: Cav: Average concentration within a dosing interval after multiple dosing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers', 'Psoriasis']}, 'referencesModule': {'references': [{'pmid': '40520205', 'type': 'DERIVED', 'citation': 'Feldmuller M, Jodl SJ, Ploeger B, Wagenfeld A, Wiesinger H, Zollmann FS, Klein S, Zhang R, Rohde B, Hochel J. Zabedosertib, a novel interleukin-1 receptor-associated kinase-4 inhibitor, shows a favorable pharmacokinetic and safety profile across multiple phase 1 studies. Front Pharmacol. 2025 May 30;16:1521505. doi: 10.3389/fphar.2025.1521505. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'To assess safety and tolerability of multiple oral doses of BAY1834845 in healthy male subjects (Part 1) and in patients with psoriasis (Part 2).\n\nTo assess the pharmacokinetic (PK) properties of total BAY1834845 in plasma after oral multiple doses of BAY1834845 in healthy male subjects (Part 1) and patients with psoriasis (Part 2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nPart 1 (healthy male subjects)\n\n* Healthy male subjects, 18 to 50 years of age (inclusive), and in good health as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory tests at screening\n* Body mass index (BMI) above or equal to 18.5 and lower or equal to 30 kg/m2 (BMI = body weight (kg) / \\[height (m)\\]2 and a body weight above or equal 50 kg Part 2 (patients with psoriasis)\n* Male patients, 18 to 70 years of age (inclusive) or female patients of non-child bearing potential, 30 to 70 years of age (inclusive)\n* Body mass index above or equal to 18.5 and lower or equal to 35 kg/m\\*2 and a body weight above 50 kg\n* A documented diagnosis of psoriasis, with a history of at least 6 months prior to study drug administration. Moderate to severe plaque psoriasis at screening, defined by: a) an involved body surface area (BSA) above or equal to 10% of BSA, b) a Psoriasis Area and Severity Index (PASI) score of above or equal, 12 c) a Physician's Global Assessment (PGA) score of above or equal 2.\n\nExclusion Criteria:\n\n* History of hypersensitivity to any of the components of the study drug\n* Any clinically relevant abnormal findings in safety laboratory parameters and ECG\n* History of tuberculosis (TB) or active or latent tuberculosis\n* Receipt of live or attenuated vaccine 90 days prior to the first dosing"}, 'identificationModule': {'nctId': 'NCT03493269', 'briefTitle': 'A Multiple Dose Study of BAY1834845 in Healthy Male Subjects and in Patients With Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics and Exploratory Pharmacodynamics of Multiple Oral Doses of BAY1834845 in Healthy Male Subjects and in Female and Male Patients With Psoriasis Over an Extended Treatment Duration', 'orgStudyIdInfo': {'id': '18385'}, 'secondaryIdInfos': [{'id': '2017-001817-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BAY1834845', 'description': 'Part 1 in healthy male subjects:\n\nDose Groups 1-4 : orally administered multiple ascending doses. The treatment will last 10 consecutive days (treatment period1) and 1 day (treatment period 2) Dose Group 5: The treatment will last 1 day (treatment period 1) and 10 consecutive days (treatment period 2)', 'interventionNames': ['Drug: BAY1834845', 'Drug: Midazolam']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Matching Placebo', 'description': 'Part 1: Matching placebo in healthy male subjects.', 'interventionNames': ['Other: Matching Placebo', 'Drug: Midazolam']}, {'type': 'EXPERIMENTAL', 'label': 'Chosen dose of BAY1834845', 'description': 'Part 2: This dose level will be adminstered in female and male patients with psoriasis', 'interventionNames': ['Drug: BAY1834845']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Part 2: The placebo will be adminstered in female and male patients with psoriasis', 'interventionNames': ['Other: Matching Placebo']}], 'interventions': [{'name': 'BAY1834845', 'type': 'DRUG', 'description': 'Orally administered.', 'armGroupLabels': ['BAY1834845', 'Chosen dose of BAY1834845']}, {'name': 'Matching Placebo', 'type': 'OTHER', 'description': 'Orally administered.', 'armGroupLabels': ['Matching Placebo', 'Placebo']}, {'name': 'Midazolam', 'type': 'DRUG', 'description': 'Part 1: Orally administered 1mg as a single dose.', 'armGroupLabels': ['BAY1834845', 'Matching Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Research Organisation GmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14050', 'city': 'Berlin', 'country': 'Germany', 'facility': 'PAREXEL GmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}