Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-01 @ 12:53 AM
Study NCT ID:
NCT01423656
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2011-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects by Dermal Application of a LEO 29102
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000592443', 'term': '2-(6-(2-(3,5-dichloro-4-pyridyl)acetyl)-2,3-dimethoxyphenoxy)-N-propylacetamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2011-07-14', 'studyFirstSubmitQcDate': '2011-08-25', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects with adverse events (AEs) and change from baseline in vital signs (blood pressure, pulse rate, respiratory rate and oral body temperature), ECG, telemetry,clinical laboratory and local tolerability assessments', 'timeFrame': '7 days after last dosing'}], 'secondaryOutcomes': [{'measure': 'LEO 29102 and metabolites in blood and urine', 'timeFrame': '72 hours after dosing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'The principal aim of this study is to obtain safety, tolerability and pharmacokinetic data when LEO 29102 is administered cutaneously as single and multiple doses to healthy subjects.\n\nThe study is divided into one single dose part, one part to compare pharmacokinetics between gender and one multiple dose part.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects will be Caucasian males and females between 18 and 55 years of age and with a body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive.\n* Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations\n\nExclusion Criteria:\n\n* Subjects who suffer from, or show signs of eczema or other skin lesions.\n* Subjects who are still participating in a clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity), or a marketed drug within the past 3 months prior to the first dosing occasion.\n* Subjects with a significant history of drug allergy as determined by the Investigator.\n* Subjects with known immunocompromised state due to treatment with immunosuppressive drugs or due to history of a disease leading to immunocompromised status.'}, 'identificationModule': {'nctId': 'NCT01423656', 'briefTitle': 'Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects by Dermal Application of a LEO 29102', 'organization': {'class': 'INDUSTRY', 'fullName': 'LEO Pharma'}, 'orgStudyIdInfo': {'id': 'LEO 29102-C06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LEO 29102', 'interventionNames': ['Drug: LEO 29102']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'LEO 29102 vehicle', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LEO 29102', 'type': 'DRUG', 'armGroupLabels': ['LEO 29102']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo Comparator: LEO 29102 vehicle', 'armGroupLabels': ['LEO 29102 vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS2 9LH', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Covance Clinical Research Unit Ltd.', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'overallOfficials': [{'name': 'Ashley Brooks, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Covance'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LEO Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}