Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-02-10 @ 3:54 AM
Study NCT ID:
NCT02936492
Status:
TERMINATED
Last Update Posted:
2017-11-08
First Post:
2016-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BAY1003803 Single and Multiple Dose Escalation, Safety, Tolerability and Pharmacokinetics Study
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': 'D009824', 'term': 'Ointments'}, {'id': 'D002990', 'term': 'Clobetasol'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D001623', 'term': 'Betamethasone'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-06', 'studyFirstSubmitDate': '2016-10-17', 'studyFirstSubmitQcDate': '2016-10-17', 'lastUpdatePostDateStruct': {'date': '2017-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cortisol serum levels for safety', 'timeFrame': 'Up to 2 weeks'}, {'measure': 'Frequency of treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Up to 2 weeks'}, {'measure': 'Nature of treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Up to 2 weeks'}], 'secondaryOutcomes': [{'measure': 'Monocytic human leukocyte antigen-DR (HLA-DR) expression (Part 1, single dose)', 'timeFrame': 'Day 1 to 3 at 8:00 am'}, {'measure': 'Monocytic human leukocyte antigen-DR (HLA-DR) expression (Part 2, multiple dose)', 'timeFrame': 'Day 1 to 8 at 8:00 am'}, {'measure': 'Maximum plasma concentration (Cmax) after single dose of BAY1003803', 'timeFrame': 'At pre-dose, 1.5, 3, 5, 7, 9, 11, 13, 15, 21, 22, 23, 24 hours'}, {'measure': 'Area under the plasma concentration vs. time curve from zero to infinity (AUC) after single dose of BAY1003803', 'timeFrame': 'At pre-dose, 1.5, 3, 5, 7, 9, 11, 13, 15, 21, 22, 23, 24, 27, 31, 35, 39, 47 hours'}, {'measure': 'Area under the curve from time zero to 22 hours [AUC(0-22)] after single dose of BAY1003803', 'timeFrame': 'At pre-dose, 1.5, 3, 5, 7, 9, 11, 13, 15, 21, 22 hours'}, {'measure': 'Maximum plasma concentration (Cmax,md) after multiple dose of BAY1003803', 'timeFrame': 'At pre-dose, 3, 7, 9, 11, 13, 22, 23 hours (Day 1); At pre-dose, 3, 7, 9, 11, 13, 22, 23, 24 hours (Day 2 and Day 6)'}, {'measure': 'Area under the curve from time zero to 24 hours [AUC(0-24)md] after multiple dose of BAY1003803', 'timeFrame': 'At pre-dose, 3, 7, 9, 11, 13, 22, 23 hours (Day 1); At pre-dose, 3, 7, 9, 11, 13, 22, 23, 24 hours (Day 2 and Day 6)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Phase I', 'Healthy volunteers'], 'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'Systemic safety following single and multiple dermal administration of BAY1003803'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subject\n* Age: 18 to 64 years (inclusive) at the first screening visit\n* Body mass index (BMI): above or equal 18 and below or equal 30 kg / m² at the first screening visit\n* Non-smoker at least 3 months prior to study start and during the study\n* Healthy skin on which reddening can be easily recognized\n\nExclusion Criteria:\n\n* A history of relevant diseases, especially incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, excretion and effect of the study drugs will not be normal, dermal diseases, diseases which present a risk for subjects to be treated with glucocorticoid receptor agonists (e.g. gastric ulcers, cornea ulcer, colitis ulcerosa, severe infections, glaucoma, diabetes, myocardial infarction, thromboembolic disease, hypertension, thyroid disease, tuberculosis, myasthenia gravis, osteoporosis, psychiatric diseases)\n* Infections and febrile illness within 4 week before the first study drug administration\n* Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them\n* Inoculations with live vaccine within 8 weeks before the first study drug administration\n* Signs of irritation or folliculitis or any other dermatological conditions in the test areas that would interfere with the planned assessments as judged by the Investigators\n* Human leukocyte antigen-DR (HLA-DR) \\< 15000 AB/monocyte'}, 'identificationModule': {'nctId': 'NCT02936492', 'briefTitle': 'BAY1003803 Single and Multiple Dose Escalation, Safety, Tolerability and Pharmacokinetics Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Escalating Dose Study for Safety, Tolerability and Pharmacokinetics After Single and Multiple Dermal Administration of Two BAY1003803 Formulation Types With Two Concentrations Each in Healthy Male Volunteers, Applying a Double-blind, Vehicle-controlled Design and Including a Positive Control Group', 'orgStudyIdInfo': {'id': '17014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BAY1003803', 'description': 'Topical treatment: dose escalating in 9 steps from 0.13 mg to 61.7 mg per subject', 'interventionNames': ['Drug: BAY1003803 0.01% lipophilic cream', 'Drug: BAY1003803 0.1% lipophilic cream', 'Drug: BAY1003803 0.01% ointment', 'Drug: BAY1003803 0.1% ointment']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Topical treatment using matching amount of placebo', 'interventionNames': ['Drug: Lipophilic cream vehicle', 'Drug: Ointment vehicle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clobetasol propionate', 'description': 'Topical treatment using 16.5 mg of clobetasol propionate per subject', 'interventionNames': ['Drug: Clobetasol propionate']}], 'interventions': [{'name': 'BAY1003803 0.01% lipophilic cream', 'type': 'DRUG', 'description': 'Topical administration for 22 h per day', 'armGroupLabels': ['BAY1003803']}, {'name': 'BAY1003803 0.1% lipophilic cream', 'type': 'DRUG', 'description': 'Topical administration for 22 h per day', 'armGroupLabels': ['BAY1003803']}, {'name': 'BAY1003803 0.01% ointment', 'type': 'DRUG', 'description': 'Topical administration for 22 h per day', 'armGroupLabels': ['BAY1003803']}, {'name': 'BAY1003803 0.1% ointment', 'type': 'DRUG', 'description': 'Topical administration for 22 h per day', 'armGroupLabels': ['BAY1003803']}, {'name': 'Lipophilic cream vehicle', 'type': 'DRUG', 'description': 'Topical administration for 22 h per day', 'armGroupLabels': ['Placebo']}, {'name': 'Ointment vehicle', 'type': 'DRUG', 'description': 'Topical administration for 22 h per day', 'armGroupLabels': ['Placebo']}, {'name': 'Clobetasol propionate', 'type': 'DRUG', 'description': 'Topical administration for 22 h per day', 'armGroupLabels': ['Clobetasol propionate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20251', 'city': 'Hamburg', 'country': 'Germany', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}