Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-02-10 @ 3:52 AM
Study NCT ID:
NCT02143856
Status:
COMPLETED
Last Update Posted:
2014-07-22
First Post:
2014-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Bioavailability of Solid Formulation of GLPG1205 With and Without Food
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722907', 'term': 'GLPG1205'}]}}, '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': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-21', 'studyFirstSubmitDate': '2014-05-18', 'studyFirstSubmitQcDate': '2014-05-18', 'lastUpdatePostDateStruct': {'date': '2014-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The amount of GLPG1205 in plasma', 'timeFrame': 'From predose up to 504 hours (Day 22) after study drug administration', 'description': 'To characterize and compare the amount of GLPG1205 in plasma ( relative bioavailability) in male healthy subjects after a single administration of a capsule formulation in a fasted versus fed condition.'}], 'secondaryOutcomes': [{'measure': 'The number of subjects with adverse events', 'timeFrame': 'From screening up to 28 (+/-2) days after last study drug administration', 'description': 'To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of adverse events (AEs)'}, {'measure': 'The number of subjects with abnormal laboratory parameters', 'timeFrame': 'From screening up to 28 (+/-2) days after last study drug administration', 'description': 'To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal laboratory parameters'}, {'measure': 'The number of subjects with abnormal vital signs', 'timeFrame': 'From screening up to 28 (+/-2) days after last study drug administration', 'description': 'To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal vital signs'}, {'measure': 'The number of subjects with abnormal electrocardiogram (ECG)', 'timeFrame': 'From screening up to 28 (+/-2) days after last study drug administration', 'description': 'To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal electrocardiogram (ECG)'}, {'measure': 'The number of subjects with abnormal physical examination', 'timeFrame': 'From screening up to 28 (+/-2) days after last study drug administration', 'description': 'To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal physical examination'}]}, '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 oral administration of GLPG1205 given as a capsule formulation in fasted versus fed conditions in male healthy subjects.\n\nAlso, the safety and tolerability of a single oral dose of GLPG1205 given as a capsule formulation under fasted and fed conditions will be assessed.'}, '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\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': 'NCT02143856', 'briefTitle': 'Oral Bioavailability of Solid Formulation of GLPG1205 With and Without Food', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galapagos NV'}, 'officialTitle': 'A Randomized, Open-label, Two-way Cross-over Study to Determine the Oral Bioavailability of GLPG1205 After Single-dose Intake in Healthy Male Subjects as a Solid Formulation, With and Without Food', 'orgStudyIdInfo': {'id': 'GLPG1205-CL-102'}, 'secondaryIdInfos': [{'id': '2013-004771-12', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '100 mg GLPG1205 fasted', 'description': 'Single dose of 100 mg GLPG1205 as two capsules of 50 mg after an overnight fast', 'interventionNames': ['Drug: 100 mg GLPG1205']}, {'type': 'EXPERIMENTAL', 'label': '100 mg GLPG1205 fed', 'description': 'Single dose of 100 mg GLPG1205 as two capsules of 50 mg exactly 30 minutes after the start of a high-fat, high-calorie breakfast', 'interventionNames': ['Drug: 100 mg GLPG1205']}], 'interventions': [{'name': '100 mg GLPG1205', 'type': 'DRUG', 'description': 'A single dose of 100 mg GLPG1205 administered as two capsules of 50 mg', 'armGroupLabels': ['100 mg GLPG1205 fasted', '100 mg GLPG1205 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': 'Frédéric Vanhoutte, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Galapagos NV'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galapagos NV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}