Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2025-12-25 @ 12:45 PM
Study NCT ID:
NCT04002895
Status:
COMPLETED
Last Update Posted:
2019-11-04
First Post:
2019-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
What the Body Does to Foliglurax in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000730045', 'term': 'foliglurax'}]}}, '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': '2019-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-01', 'studyFirstSubmitDate': '2019-06-27', 'studyFirstSubmitQcDate': '2019-06-27', 'lastUpdatePostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total amount of radioactivity excreted', 'timeFrame': 'Before dosing until day 11', 'description': 'Cumulative amount of radioactivity excreted in urine and faeces'}, {'measure': 'AUC(0-inf) foliglurax', 'timeFrame': 'From day 1 until day 11', 'description': 'Area under the plasma concentration time curve from zero to infinity'}, {'measure': 'Cmax foliglurax', 'timeFrame': 'From day 1 until day 11', 'description': 'Maximum observed plasma concentration'}, {'measure': 'CL/F foliglurax', 'timeFrame': 'From Day 1 until Day 11', 'description': 'Oral clearance for foliglurax in plasma'}, {'measure': 'Total recovery of the administered dose', 'timeFrame': 'Before dosing until day 11', 'description': '% of dose in urine and faeces'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study evaluates how the body takes up and gets rid of foliglurax after swallowing a liquid dose.', 'detailedDescription': 'Six healthy men will swallow a liquid dose of 80 mg that is labelled with a small dose of radioactive tracer. Blood, urine and faeces will be collected to measure how much of the radioactivity gets into the blood stream and ends up in the urine and faeces. It is also measured how the body gets rid of the radioactivity and how quickly.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Healthy men with a body mass index (BMI) of 19-30 kg/m2 (inclusive), and with a body weight of minimum 60 kg at the Screening Visit.\n\nExclusion Criteria:\n\n\\- The subject has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.\n\nOther inclusion and exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT04002895', 'acronym': 'Foliglurax', 'briefTitle': 'What the Body Does to Foliglurax in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'H. Lundbeck A/S'}, 'officialTitle': 'Interventional, Open-label, Single-dose Study Investigating the Absorption, Metabolism and Excretion (AME) of Foliglurax (Lu AF99757) Following Oral Dosing of 14C-foliglurax to Healthy Men', 'orgStudyIdInfo': {'id': '18154A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Foliglurax', 'interventionNames': ['Drug: Foliglurax']}], 'interventions': [{'name': 'Foliglurax', 'type': 'DRUG', 'description': 'Single oral dose of 80 mg \\[14C\\]-foliglurax(93µCi/3.44 MBq), 1mg/mL oral solution (prepared from \\[14C\\]-foliglurax powder for oral solution)', 'armGroupLabels': ['Foliglurax']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'GB1050 Covance', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'overallOfficials': [{'name': 'Email contact via H. Lundbeck A/S', 'role': 'STUDY_DIRECTOR', 'affiliation': 'LundbeckClinicalTrials@Lundbeck.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lundbeck A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}