Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT03450720
Status:
COMPLETED
Last Update Posted:
2018-03-19
First Post:
2018-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of GLPG2737 in Male Subjects With Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-15', 'studyFirstSubmitDate': '2018-02-23', 'studyFirstSubmitQcDate': '2018-02-23', 'lastUpdatePostDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax) of GLPG2737and its metabolite.', 'timeFrame': 'Between day 1 pre-dose and 48 hours post-dose.', 'description': 'To characterize the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.'}, {'measure': 'Time of occurrence of Cmax for GLPG2737(tmax)', 'timeFrame': 'Between day 1 pre-dose and 48 hours post-dose.', 'description': 'To determine PK parameters of GLPG2737 and its metabolite after given a single oral dose in CF subjects.'}, {'measure': 'Plasma concentration observed at 24 hours post-dos (C24h)', 'timeFrame': 'Between day 1 pre-dose and 48 hours post-dose.', 'description': 'To assess PK parameters of GLPG2737 and its metabolite after given a single oral dose in CF subjects.'}, {'measure': 'Area under the plasma concentration-time curve for GLPG2737 (AUC0-24h)', 'timeFrame': 'Between day 1 pre-dose and 48 hours post-dose.', 'description': 'To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.'}, {'measure': 'Area under the plasma concentration-time curve from time zero until 48 hours post-dose (AUC0-48h)', 'timeFrame': 'Between day 1 pre-dose and 48 hours post-dose.', 'description': 'To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.'}, {'measure': 'Terminal plasma elimination rate constant (ke)', 'timeFrame': 'Between day 1 pre-dose and 48 hours post-dose.', 'description': 'To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.'}, {'measure': 'Apparent terminal elimination half-life ( t1/2)', 'timeFrame': 'Between day 1 pre-dose and 48 hours post-dose.', 'description': 'To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.'}], 'secondaryOutcomes': [{'measure': 'Number of subjects with adverse events.', 'timeFrame': 'Between screening and 15 days post-dose', 'description': 'To determine the safety and tolerability of GLPG2737 after a single oral dose in CF subjects.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'This is a single dose, open label study in adult male subjects with cystic fibrosis to investigate the pharmacokinetics, safety and tolerability of GLPG2737.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male subject ≥18 years of age on the day of signing the informed consent form (ICF).\n* A confirmed clinical diagnosis of CF.\n* Two mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene belonging to class I and/or class II and/or class III (documented in the subject's medical record or CF registry).\n* Weight ≥40 kg.\n* Exocrine pancreatic insufficiency (documented in the subject's medical record).\n* Stable concomitant medication regimen for at least 2 weeks prior to study drug administration.\n* Forced expiratory volume in one second (FEV1) ≥40% of predicted normal for age, gender and height at screening (pre- or postbronchodilator).\n\nExclusion Criteria:\n\n* History of clinically meaningful unstable or uncontrolled chronic disease that makes the subject unsuitable for inclusion in the study in the opinion of the investigator.\n* Unstable pulmonary status or respiratory tract infection (including rhinosinusitis) requiring a change in therapy within 2 weeks prior to study drug administration.\n* History of hepatic cirrhosis with portal hypertension (e.g.,signs/symptoms of splenomegaly, esophageal varices).\n* Use of CFTR modulator therapy (e.g., lumacaftor or ivacaftor) within 2 weeks prior to study drug administration."}, 'identificationModule': {'nctId': 'NCT03450720', 'briefTitle': 'Pharmacokinetics of GLPG2737 in Male Subjects With Cystic Fibrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galapagos NV'}, 'officialTitle': 'Evaluation of the Pharmacokinetics, Safety and Tolerability of a Single Dose of GLPG2737 Administered as Oral Suspension in Male Subjects With Cystic Fibrosis', 'orgStudyIdInfo': {'id': 'GLPG2737-CL-104'}, 'secondaryIdInfos': [{'id': '2017-000449-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GLPG2737 single dose.', 'description': 'Single dose of GLPG2737 oral suspension.', 'interventionNames': ['Drug: GLPG2737 single dose']}], 'interventions': [{'name': 'GLPG2737 single dose', 'type': 'DRUG', 'description': 'GLPG2737 oral suspension, single dose', 'armGroupLabels': ['GLPG2737 single dose.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ KU Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Olivier Van de Steen, MD MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Galapagos NV'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galapagos NV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}