Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 10:09 PM
Study NCT ID:
NCT04856358
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2021-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate How Well Single and Multiple Doses of GLPG3121-modified Release Formulation Are Tolerated in Healthy, Adult Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Part 1 Single Ascending Dose (SAD) and Part 2 Multiple Ascending Dose (MAD) are randomized, double-blind, placebo-controlled; Part 3 Food-effect (FE) is randomized, open-label, crossover'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-13', 'studyFirstSubmitDate': '2021-04-14', 'studyFirstSubmitQcDate': '2021-04-19', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency and severity of treatment emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations', 'timeFrame': 'From screening through study completion, an average of 8 months', 'description': 'To evaluate the safety and tolerability of single and multiple ascending oral doses of GLPG3121-modified-release formulation (GLPG3121-MR), in adult, healthy, male subjects compared with placebo'}], 'secondaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax) of GLPG3121 in SAD', 'timeFrame': 'Between Day 1 pre-dose and Day 6', 'description': 'To evaluate the pharmacokinetics (PK) of single ascending oral doses of GLPG3121 in adult, healthy, male subjects'}, {'measure': "Cmax of GLPG3121's main metabolite in SAD", 'timeFrame': 'Between Day 1 pre-dose and Day 6', 'description': "To evaluate the PK of single ascending oral doses of GLPG3121's metabolite in adult, healthy, male subjects"}, {'measure': 'Cmax of GLPG3121 in MAD', 'timeFrame': 'Between Day 1 pre-dose and Day 19', 'description': 'To evaluate the PK of multiple ascending oral doses of GLPG3121 in adult, healthy, male subjects'}, {'measure': "Cmax of GLPG3121's main metabolite in MAD", 'timeFrame': 'Between Day 1 pre-dose and Day 19', 'description': "To evaluate the PK of multiple ascending oral doses of GLPG3121's main metabolite in adult, healthy, male subjects"}, {'measure': 'Area under the plasma concentration-time curve (AUC) of GLPG3121 in SAD', 'timeFrame': 'Between Day 1 pre-dose and Day 6', 'description': 'To evaluate the PK of single ascending oral doses of GLPG3121 in adult, healthy, male subjects'}, {'measure': "AUC of GLPG3121's main metabolite in SAD", 'timeFrame': 'Between Day 1 pre-dose and Day 6', 'description': "To evaluate the PK of single ascending oral doses of GLPG3121's main metabolite in adult, healthy, male subjects"}, {'measure': 'AUC of GLPG3121 in MAD', 'timeFrame': 'Between Day 1 pre-dose and Day 19', 'description': 'To evaluate the PK of multiple ascending oral doses of GLPG3121 metabolite in adult, healthy, male subjects'}, {'measure': "AUC of GLPG3121's main metabolite in MAD", 'timeFrame': 'Between Day 1 pre-dose and Day 19', 'description': "To evaluate the PK of multiple ascending oral doses of GLPG3121's main metabolite in adult, healthy, male subjects"}, {'measure': 'Terminal elimination half-life (t1/2) of GLPG3121 in SAD', 'timeFrame': 'Between Day 1 pre-dose and Day 6', 'description': 'To evaluate the PK of single ascending oral doses of GLPG3121 in adult, healthy, male subjects'}, {'measure': "t1/2 of GLPG3121's main metabolite in SAD", 'timeFrame': 'Between Day 1 pre-dose and Day 6', 'description': "To evaluate the PK of single ascending oral doses of GLPG3121's main metabolite in adult, healthy, male subjects"}, {'measure': 't1/2 of GLPG3121 in MAD', 'timeFrame': 'Between Day 1 pre-dose and Day 19', 'description': 'To evaluate the PK of multiple ascending oral doses of GLPG3121 in adult, healthy, male subjects'}, {'measure': "t1/2 of GLPG3121's main metabolite in MAD", 'timeFrame': 'Between Day 1 pre-dose and Day 19', 'description': "To evaluate the PK of multiple ascending oral doses of GLPG3121's main metabolite in adult, healthy, male subjects"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to examine the safety and tolerability of GLPG3121-modified release formulation when given to healthy male subjects once as a single dose or multiple times over a period of 14 days in fasting condition or after a standard breakfast.\n\nThe study will evaluate how the body absorbs and breaks down GLPG3121, and how GLPG3121 and the major breakdown product of GLPG3121 are eliminated from the body. In addition, the study will investigate the effect of food (high-fat) after a single oral dose of GLPG3121 as modified release tablet.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male between 18 and 55 years of age (extremes included), on the date of signing the informed consent form (ICF).\n* A body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.\n* Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests, available at screening and prior to randomization. Hemoglobin, neutrophil, lymphocyte, and platelet counts must be above the lower limit of normal range. Total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and serum creatinine must be no greater than the upper limit of normal (ULN). Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator.\n* Subject must be able and willing to comply with restrictions on prior and concomitant medication.\n* Negative screen for drugs (amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, tricyclic antidepressants) and alcohol.\n\nThis list only contains the key inclusion criteria.\n\nExclusion Criteria:\n\n* Known hypersensitivity to investigational product (IP) ingredients or history of a significant allergic reaction to IP ingredients as determined by the investigator.\n* Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or history of hepatitis from any cause with the exception of hepatitis A that was resolved at least 3 months prior to first dosing of the IP.\n* History of or a current immunosuppressive condition (e.g. human immunodeficiency virus \\[HIV\\] infection).\n* Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first dosing of the IP.\n* Presence or sequelae of gastrointestinal, liver, kidney (estimated glomerular filtration rate \\[eGFR\\] \\<=90 mL/min/1.73 m2, using the Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] formula) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.\n\nThis list only contains the key exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT04856358', 'briefTitle': 'A Study to Evaluate How Well Single and Multiple Doses of GLPG3121-modified Release Formulation Are Tolerated in Healthy, Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galapagos NV'}, 'officialTitle': 'A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of GLPG3121-modified Release Formulation in Adult, Healthy, Male Subjects', 'orgStudyIdInfo': {'id': 'GLPG3121-CL-103'}, 'secondaryIdInfos': [{'id': '2020-004174-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GLPG3121 SAD', 'description': 'Single doses of GLPG3121 at up to 3 dose levels in ascending order', 'interventionNames': ['Drug: GLPG3121']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo SAD', 'description': 'Single doses of placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'GLPG3121 MAD', 'description': 'Multiple doses of GLPG3121 at up to 3 dose levels in ascending order', 'interventionNames': ['Drug: GLPG3121']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo MAD', 'description': 'Multiple doses of placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'GLPG3121 FE fed', 'description': 'Single dose of GLPG3121 in fed state', 'interventionNames': ['Drug: GLPG3121']}, {'type': 'EXPERIMENTAL', 'label': 'GLPG3121 FE fasted', 'description': 'Single dose of GLPG3121 in fasted state', 'interventionNames': ['Drug: GLPG3121']}], 'interventions': [{'name': 'GLPG3121', 'type': 'DRUG', 'description': 'GLPG3121 modified-release tablet', 'armGroupLabels': ['GLPG3121 FE fasted', 'GLPG3121 FE fed', 'GLPG3121 MAD', 'GLPG3121 SAD']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo', 'armGroupLabels': ['Placebo MAD', 'Placebo SAD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Research Organisation GmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Magdalena Petkova, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Galapagos NV'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galapagos NV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}