Ignite Creation Date:
2025-12-24 @ 1:40 PM
Ignite Modification Date:
2025-12-28 @ 11:10 PM
Study NCT ID:
NCT01278095
Status:
COMPLETED
Last Update Posted:
2011-03-24
First Post:
2011-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Bioavailability of GLPG0555 in Different Solid Formulations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-23', 'studyFirstSubmitDate': '2011-01-14', 'studyFirstSubmitQcDate': '2011-01-14', 'lastUpdatePostDateStruct': {'date': '2011-03-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioavailability of solid formulation', 'timeFrame': '72 hrs'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability of single doses of GLPG0555', 'timeFrame': 'up to 10 days postdose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Safety', 'Tolerability', 'Pharmacokinetics'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare the pharmacokinetics of a solid capsule formulation of GLPG0555 with a nanosuspension, and to assess safety and tolerability of a single dose of GLPG0555.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy male\n* BMI between 18-30 kg/m², inclusive.\n\nExclusion Criteria:\n\n* significantly abnormal platelet function or coagulopathy\n* smoking\n* drug or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT01278095', 'briefTitle': 'Oral Bioavailability of GLPG0555 in Different Solid Formulations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galapagos NV'}, 'officialTitle': 'A Randomized, Open Label, 3-way Crossover Study to Compare the Oral Bioavailability of GLPG0555 After Single-dose Intake in Healthy Subjects as a Solid Dispersion Formulation, With and Without Food, Relative to a Nanosuspension Formulation', 'orgStudyIdInfo': {'id': 'GLPG0555-CL-103'}, 'secondaryIdInfos': [{'id': '2010-022457-42', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GLPG0555 solid dispersion, fasting', 'description': '50 mg as solid dispersion capsule, in fasting condition', 'interventionNames': ['Drug: GLPG0555 solid dispersion']}, {'type': 'EXPERIMENTAL', 'label': 'GLPG0555 solid dispersion, fed', 'description': '50 mg as solid dispersion capsule, after breakfast', 'interventionNames': ['Drug: GLPG0555 solid dispersion']}, {'type': 'EXPERIMENTAL', 'label': 'GLPG0555 nanosuspension, fed', 'description': '50 mg as nanosuspension, given after breakfast', 'interventionNames': ['Drug: GLPG0555 nanosuspension']}], 'interventions': [{'name': 'GLPG0555 solid dispersion', 'type': 'DRUG', 'description': 'solid dispersion capsules, 50 mg, single dose', 'armGroupLabels': ['GLPG0555 solid dispersion, fasting', 'GLPG0555 solid dispersion, fed']}, {'name': 'GLPG0555 nanosuspension', 'type': 'DRUG', 'description': 'Nanosuspension, 50 mg, single dose', 'armGroupLabels': ['GLPG0555 nanosuspension, fed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2060', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'SGS Stuivenberg', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}], 'overallOfficials': [{'name': "Gerben van 't Klooster, PhD", 'role': 'STUDY_DIRECTOR', 'affiliation': 'Galapagos NV'}, {'name': 'Jos Leempoels, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SGS Stuivenberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galapagos NV', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Senior Vice President Development', 'oldOrganization': 'Galapagos'}}}}