Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-01-29 @ 7:35 AM
Study NCT ID:
NCT02179502
Status:
COMPLETED
Last Update Posted:
2015-09-22
First Post:
2014-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First-in-Human Single and Multiple Dose of GLPG1690
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000621178', 'term': 'GLPG1690'}, {'id': 'D013535', 'term': 'Suspensions'}], 'ancestors': [{'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-20', 'studyFirstSubmitDate': '2014-06-28', 'studyFirstSubmitQcDate': '2014-06-28', 'lastUpdatePostDateStruct': {'date': '2015-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects with adverse events', 'timeFrame': 'Between screening and 7-10 days after the last dose', 'description': 'To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of adverse events'}, {'measure': 'Number of subjects with abnormal laboratory parameters', 'timeFrame': 'Between screening and 7-10 days after the last dose', 'description': 'To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after single and multiple oral dose in healthy subjects in terms of abnormal laboratory parameters'}, {'measure': 'Number of subjects with abnormal vital signs', 'timeFrame': 'Between screening and 7-10 days after the last dose', 'description': 'To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of abnormal vital signs'}, {'measure': 'Number of subjects with abnormal electrocardiogram', 'timeFrame': 'Between screening and 7-10 days after the last dose', 'description': 'To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of abnormal electrocardiogram'}, {'measure': 'Number of subjects with abnormal physical examination', 'timeFrame': 'Between screening and 7-10 days after the last dose', 'description': 'To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of abnormal physical examination'}], 'secondaryOutcomes': [{'measure': 'The amount of GLPG1690 in plasma', 'timeFrame': 'Between Day 1 predose and 48 hours after the (last) dose', 'description': 'To characterize the amount of GLPG1690 in plasma over time - pharmacokinetics (PK) - after a single and multiple oral dose in healthy subjects, either as liquid or solid formulation'}, {'measure': 'The amount of GLPG1690 in urine', 'timeFrame': 'Between Day 1 predose and 24 hours after the (last) dose', 'description': 'To characterize the amount of GLPG1690 in urine over time - pharmacokinetics (PK) - after a single and multiple oral dose in healthy subjects, either as liquid or solid formulation'}, {'measure': 'Ratio of 6-b-hydroxycortisol/cortisol in urine', 'timeFrame': 'Twelve hours before dosing on Day 1 and Day 14', 'description': 'To assess the potential of CYP3A4 induction after repeated dosing with GLPG1690 by means of the ratio of 6-b-hydroxycortisol/cortisol in urine'}, {'measure': 'Levels of biomarker in plasma', 'timeFrame': 'Day 1 predose up to 48 hours post (last) dose', 'description': 'To characterize the pharmacodynamics (PD) of GLPG1690 by means of reduction of levels of biomarker by GLPG1690 compared to placebo in plasma after single and multiple oral dose in healthy subjects'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '31012984', 'type': 'DERIVED', 'citation': 'van der Aar E, Desrivot J, Dupont S, Heckmann B, Fieuw A, Stutvoet S, Fagard L, Van de Wal K, Helmer E. Safety, Pharmacokinetics, and Pharmacodynamics of the Autotaxin Inhibitor GLPG1690 in Healthy Subjects: Phase 1 Randomized Trials. J Clin Pharmacol. 2019 Oct;59(10):1366-1378. doi: 10.1002/jcph.1424. Epub 2019 Apr 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1690 given to healthy male subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1690 given to healthy male subjects daily for 14 days compared to placebo, will be evaluated.\n\nFurthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1690 present in the blood and urine (pharmacokinetics) as well as the reduction of biomarker levels by GLPG1690 in plasma samples (pharmacodynamics) will be characterized compared to placebo.\n\nThe pharmacokinetics of a solid dosage formulation of GLPG1690 will be compared with those of a liquid dosage formulation of GLPG1690.\n\nAlso, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1690 will be explored.'}, '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': 'NCT02179502', 'briefTitle': 'First-in-Human Single and Multiple Dose of GLPG1690', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galapagos NV'}, 'officialTitle': 'Randomized, Double-blind, Placebo-controlled, Dose-escalation Study for the Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG1690 in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'GLPG1690-CL-101'}, 'secondaryIdInfos': [{'id': '2014-000981-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GLPG1690 single dose', 'description': 'Single oral dose of GLPG1690 suspension or solid formulation - ascending doses', 'interventionNames': ['Drug: GLPG1690 single ascending doses']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo single dose', 'description': 'Single oral dose of placebo suspension or solid formulation', 'interventionNames': ['Drug: Placebo single ascending doses']}, {'type': 'EXPERIMENTAL', 'label': 'GLPG1690 multiple doses', 'description': 'Multiple oral doses of GLPG1690 suspension - ascending doses', 'interventionNames': ['Drug: GLPG1690, multiple ascending doses, oral suspension']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo multiple doses', 'description': 'Multiple oral doses of placebo suspension', 'interventionNames': ['Drug: Placebo, multiple ascending doses, oral suspension']}], 'interventions': [{'name': 'GLPG1690 single ascending doses', 'type': 'DRUG', 'description': 'Single dose, oral suspension or solid formulation, starting dose of 20mg escalating up to 1500mg', 'armGroupLabels': ['GLPG1690 single dose']}, {'name': 'Placebo single ascending doses', 'type': 'DRUG', 'description': 'Single dose, oral suspension or solid formulation matching placebo', 'armGroupLabels': ['Placebo single dose']}, {'name': 'GLPG1690, multiple ascending doses, oral suspension', 'type': 'DRUG', 'description': 'Multiple doses, daily for 14 days, oral suspension, anticipated doses: 300mg to 1000mg', 'armGroupLabels': ['GLPG1690 multiple doses']}, {'name': 'Placebo, multiple ascending doses, oral suspension', 'type': 'DRUG', 'description': 'Multiple doses, daily for 14 days, oral suspension matching placebo', 'armGroupLabels': ['Placebo multiple doses']}]}, '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'}}}}