Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-03-01 @ 10:22 PM
Study NCT ID:
NCT00989703
Status:
COMPLETED
Last Update Posted:
2012-02-20
First Post:
2009-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GLPG0259 Multiple Ascending Dose and Methotrexate Drug-drug Interaction (DDI) in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008727', 'term': 'Methotrexate'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-17', 'studyFirstSubmitDate': '2009-10-02', 'studyFirstSubmitQcDate': '2009-10-02', 'lastUpdatePostDateStruct': {'date': '2012-02-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of oral multiple ascending doses', 'timeFrame': 'up to 10 days postdose'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics of multiple oral doses', 'timeFrame': 'up to 10 days postdose'}, {'measure': 'To explore the pharmacokinetic interaction between GLPG0259 and methotrexate (MTX).', 'timeFrame': 'up to 10 days postdose'}, {'measure': 'To explore biomarkers of GLPG0259 activity after multiple oral administrations.', 'timeFrame': 'up to 24 hours postdose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Safety', 'Tolerability', 'Pharmacokinetics'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the safety and tolerability of multiple increasing oral doses of GLPG0259 compared to placebo.\n\nAlso, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0259 after multiple increasing oral doses, and potential drug-drug interaction with single dose methotrexate 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, inclusive.\n\nExclusion Criteria:\n\n* significantly abnormal platelet function or coagulopathy\n* smoking\n* drug or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT00989703', 'briefTitle': 'GLPG0259 Multiple Ascending Dose and Methotrexate Drug-drug Interaction (DDI) in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galapagos NV'}, 'officialTitle': 'Double Blind, Placebo Controlled, Dose Ranging and Methotrexate Interaction Study for the Assessment of Safety, Tolerability and Pharmacokinetics (PK) of Multiple Oral Doses of GLPG0259 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'GLPG0259-CL-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'GLPG0259 25/50/75 mg/day for 14 days', 'interventionNames': ['Drug: GLPG0259', 'Drug: Methotrexate']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'placebo for 14 days', 'interventionNames': ['Drug: placebo', 'Drug: Methotrexate']}], 'interventions': [{'name': 'placebo', 'type': 'DRUG', 'description': 'oral solution, daily for 14 days', 'armGroupLabels': ['2']}, {'name': 'GLPG0259', 'type': 'DRUG', 'description': 'oral solution', 'armGroupLabels': ['1']}, {'name': 'Methotrexate', 'type': 'DRUG', 'otherNames': ['Ledertrexate®'], 'description': '7.5 mg (3 tablets, 2.5 mg/tablet) on study days D-1 and D14', 'armGroupLabels': ['1', '2']}]}, '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': {'type': 'SPONSOR'}}}}