Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT01322451
Status:
COMPLETED
Last Update Posted:
2011-03-24
First Post:
2011-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Bioavailability of Two Solid Formulations of GLPG0259.
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': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-23', 'studyFirstSubmitDate': '2011-03-22', 'studyFirstSubmitQcDate': '2011-03-23', 'lastUpdatePostDateStruct': {'date': '2011-03-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioavailability of two solid dosage formulations of GLPG0259', 'timeFrame': 'up to 96 hours postdose'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability of GLPG0259', 'timeFrame': 'up to 96 hours postdose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Safety', 'Tolerability', 'Pharmacokinetics'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the relative bioavailability of two solid oral formulations of GLPG0259 administered after a meal.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy male, age 18-50 years\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': 'NCT01322451', 'briefTitle': 'Oral Bioavailability of Two Solid Formulations of GLPG0259.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galapagos NV'}, 'officialTitle': 'A Randomized, Open Label, 2-way Crossover Study to Compare the Oral Bioavailability of 2 Solid Dose Formulations of GLPG0259 After Single-dose Intake in Healthy Subjects', 'orgStudyIdInfo': {'id': 'GLPG0259-CL-104'}, 'secondaryIdInfos': [{'id': '2010-022456-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single oral dose, single capsule', 'interventionNames': ['Drug: GLPG0259 free base']}, {'type': 'EXPERIMENTAL', 'label': 'Single oral dose, two capsules', 'interventionNames': ['Drug: GLPG0259 fumarate']}], 'interventions': [{'name': 'GLPG0259 fumarate', 'type': 'DRUG', 'description': 'single oral dose, two capsules each containing 25 mg of GLPG0259 fumarate', 'armGroupLabels': ['Single oral dose, two capsules']}, {'name': 'GLPG0259 free base', 'type': 'DRUG', 'description': 'single oral dose, GLPG0259, 50 mg solid formulation', 'armGroupLabels': ['Single oral dose, single capsule']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antwerp', 'country': 'Belgium', 'facility': 'SGS Stuivenberg', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}], 'overallOfficials': [{'name': 'Johan Beetens, PharmD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Galapagos NV'}, {'name': 'Lien Gheyle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SGS Stuivenberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galapagos NV', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Senior Vice President Development', 'oldOrganization': 'Galapagos NV'}}}}