Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT01130818
Status:
COMPLETED
Last Update Posted:
2024-03-01
First Post:
2010-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
First-in-Human Single Ascending Dose of GLPG0492
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C577110', 'term': '4-(4-(hydroxymethyl)-3-methyl-2,5-dioxo-4-phenylimidazolidin-1-yl)-2-(trifluoromethyl)benzonitrile'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-29', 'studyFirstSubmitDate': '2010-05-20', 'studyFirstSubmitQcDate': '2010-05-25', 'lastUpdatePostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of single ascending doses in healthy young and elderly subjects.', 'timeFrame': 'up to 10 days postdose'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics of single oral doses (solution) in young and elderly subjects.', 'timeFrame': 'up to 10 days postdose'}, {'measure': 'Determine oral bioavailability of GLPG0492 given to elderly subjects as oral solution or solid dosage form with or without food.', 'timeFrame': 'up to 10 days postdose'}, {'measure': 'Determine the maximum tolerated dose in young subjects.', 'timeFrame': 'Up to 10 days postdose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Safety', 'Tolerability', 'Pharmacokinetics', 'Bioavailability (solid vs solution, fasting vs fed)', 'Young healthy subjects', 'Elderly healthy subjects'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) oral dose of GLPG0492 compared to placebo in healthy subjects.\n\nAlso, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0492 after single oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined. Oral bioavailability (solution vs solid capsule fasting or fed) is evaluated in healthy elderly subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy male, age 18-50 years (young subjects) OR ≥60 years (elderly subjects)\n* BMI between 18-30 kg/m², inclusive\n* non-smoker\n\nExclusion Criteria:\n\n* elevated PSA\n* drug or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT01130818', 'briefTitle': 'First-in-Human Single Ascending Dose of GLPG0492', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galapagos NV'}, 'officialTitle': 'Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of GLPG0492 in Healthy Subjects and Open Relative Bioavailability Study of Oral Solution Versus Solid Formulation, Fasted and Fed, in Elderly Subjects', 'orgStudyIdInfo': {'id': 'GLPG0492-CL-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'single ascending doses', 'interventionNames': ['Drug: GLPG0492']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'single dose placebo', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'single dose, oral solution, 50 mg', 'interventionNames': ['Drug: GLPG0492']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'single dose, capsules (fasting)', 'interventionNames': ['Drug: GLPG0492']}, {'type': 'EXPERIMENTAL', 'label': '5', 'description': 'single dose, capsules (fed)', 'interventionNames': ['Drug: GLPG0492']}], 'interventions': [{'name': 'GLPG0492', 'type': 'DRUG', 'description': 'single ascending doses, oral solution (25 to max. 120 mg/intake, 10 to 200 mg/mL)', 'armGroupLabels': ['1', '3']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'single dose, oral solution', 'armGroupLabels': ['2']}, {'name': 'GLPG0492', 'type': 'DRUG', 'description': 'single dose, solid formulation, 50 mg (2\\*25 mg/capsule), fasting', 'armGroupLabels': ['4']}, {'name': 'GLPG0492', 'type': 'DRUG', 'description': 'single dose, solid formulation, 50 mg (2\\*25 mg/capsule), after high fat breakfast', 'armGroupLabels': ['5']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antwerp', 'country': 'Belgium', 'facility': 'SGS Stuivenberg', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}], 'overallOfficials': [{'name': 'Florence Namour, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Galapagos NV'}, {'name': 'Sofie Mesens, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SGS Stuivenberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galapagos NV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}