Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-01 @ 4:46 AM
Study NCT ID:
NCT01915667
Status:
COMPLETED
Last Update Posted:
2013-09-17
First Post:
2013-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Bioavailability of Two Solid Formulations of GLPG0634
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C584571', 'term': 'GLPG0634'}, {'id': 'D002214', 'term': 'Capsules'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-16', 'studyFirstSubmitDate': '2013-08-02', 'studyFirstSubmitQcDate': '2013-08-02', 'lastUpdatePostDateStruct': {'date': '2013-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The amount of GLPG0634 and metabolite in plasma after a single dose of GLPG0634 as capsules or tablets', 'timeFrame': 'From predose (before first study drug administration) up to 144 hours post last study drug administration', 'description': 'To characterize and compare the amount of GLPG0634 and metabolite in plasma (relative bioavailability) in male healthy subjects after a single administration of either a capsule or tablet formulation in a fasted condition. For the tablet formulation, also the amount of GLPG0634 and metabolite in plasma will be evaluated after fasting and in fed condition.'}], 'secondaryOutcomes': [{'measure': 'The number of subjects with adverse events, abnormal lab tests, physical examinations, vital signs and ECG after a single dose of GLPG0634 as capsules or tablets', 'timeFrame': 'Between screening and 7-10 days after the last dose', 'description': 'To evaluate the safety and tolerability of GLPG0634 after a single oral dose as capsules or tablets, either fasted or fed, in male healthy subjects in terms of adverse events (AEs), abnormalities in laboratory tests, physical examinations, vital signs and electrocardiogram (ECG)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the amount of compound present in the blood (relative bioavailability) after a single administration of GLPG0634 as a tablet versus a capsule in fasted conditions in male healthy subjects.\n\nAlso, the effect of food on the bioavailability of the tablet formulation will be studied as well as the safety and tolerability of single oral doses of GLPG0634 given either as capsule or tablet.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male, age 40-60 years\n* BMI between 18-30 kg/m2\n\nExclusion Criteria:\n\n* Any condition that might interfere with the procedures or tests in this study\n* Drug or alcohol abuse\n* Smoking'}, 'identificationModule': {'nctId': 'NCT01915667', 'briefTitle': 'Oral Bioavailability of Two Solid Formulations of GLPG0634', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galapagos NV'}, 'officialTitle': 'Bioavailability Study Comparing Two Solid Oral Formulations of GLPG0634 in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'GLPG0634-CL-107'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GLPG0634 capsule fasted', 'description': 'Single dose of GLPG0634 as capsules in fasted condition', 'interventionNames': ['Drug: 200 mg GLPG0634 as capsules, fasted']}, {'type': 'EXPERIMENTAL', 'label': 'GLPG0634 tablet fasted', 'description': 'Single dose of GLPG0634 as tablets in fasted condition', 'interventionNames': ['Drug: 200 mg GLPG0634 as tablets, fasted']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GLPG0634 tablet fed', 'description': 'Single dose of GLPG0634 as tablets in fed condition', 'interventionNames': ['Drug: 200 mg GLPG0634 as tablets, fed']}], 'interventions': [{'name': '200 mg GLPG0634 as capsules, fasted', 'type': 'DRUG', 'description': 'single oral dose of 200 mg GLPG0634 given as capsules in fasted condition', 'armGroupLabels': ['GLPG0634 capsule fasted']}, {'name': '200 mg GLPG0634 as tablets, fasted', 'type': 'DRUG', 'description': 'single oral dose of 200 mg GLPG0634 given as tablets in fasted condition', 'armGroupLabels': ['GLPG0634 tablet fasted']}, {'name': '200 mg GLPG0634 as tablets, fed', 'type': 'DRUG', 'description': 'single oral dose of 200 mg GLPG0634 given as tablets in fed condition', 'armGroupLabels': ['GLPG0634 tablet fed']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antwerp', 'state': 'Antwerp', 'country': 'Belgium', 'facility': 'SGS LSS Clinical Pharmacology Unit Antwerp', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}], 'overallOfficials': [{'name': 'Pille Harrison, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Galapagos NV'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galapagos NV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}