Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT04952467
Status:
COMPLETED
Last Update Posted:
2022-01-14
First Post:
2021-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single-dose Mass Balance Recovery and Metabolite Profile and Identification of 14C-XEN1101
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-13', 'studyFirstSubmitDate': '2021-06-27', 'studyFirstSubmitQcDate': '2021-06-27', 'lastUpdatePostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total radioactivity excreted in urine and faeces following oral administration of XEN1101', 'timeFrame': 'From Screening up to Day 57 post-dose', 'description': 'Cumulative amount of total radioactivity excreted in urine and feces combined (CumAe(total)) and expressed as a % of the radioactive dose administered (Cum%Ae(total)) following oral administration of 14C-XEN1101'}], 'secondaryOutcomes': [{'measure': '14C Metabolite profiling in of plasma, urine and feces', 'timeFrame': 'From Screening up to Day 57 post-dose', 'description': 'Chemical structure of each metabolite classified as \\>10% (by AUC) of total radioactivity in plasma and \\>10% dose excreted in urine and faeces following oral administration of XEN1101'}, {'measure': 'Pharmacokinetic (PK) data for 14C-XEN1101; Tmax', 'timeFrame': 'From Screening up to Day 57 post-dose', 'description': 'Time of maximum observed concentration for XEN1101 and metabolites in plasma and for total radioactivity in plasma and whole blood following oral administration of 14C-XEN1101'}, {'measure': 'PK data for 14C-XEN1101; Cmax', 'timeFrame': 'From Screening up to Day 57 post-dose', 'description': 'Maximum observed concentration for XEN1101 and metabolites in plasma and for total radioactivity in plasma and whole blood following oral administration of 14C-XEN1101'}, {'measure': 'PK data for 14C-XEN1101; T1/2', 'timeFrame': 'From Screening up to Day 57 post-dose', 'description': 'Terminal elimination half-life for XEN1101 and metabolites in plasma and for total radioactivity in plasma and whole blood following oral administration of 14C-XEN1101'}, {'measure': 'Mass balance data for 14C-XEN1101 in urine', 'timeFrame': 'From Screening up to Day 57 post-dose', 'description': 'CumAe(urine)expressed as a percentage of the radioactive dose administered (Cum%Ae(urine))'}, {'measure': 'Mass balance data for 14C-XEN1101 in feces', 'timeFrame': 'From Screening up to Day 57 post-dose', 'description': 'CumAe(feces) expressed as a percentage of the radioactive dose administered Cum%Ae(feces)'}, {'measure': 'Plasma whole blood concentration ratios for total radioactivity', 'timeFrame': 'From Screening up to Day 57 post-dose', 'description': 'Evaluation of whole blood:plasma concentration ratios for total radioactivity for corresponding time points'}, {'measure': 'Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations', 'timeFrame': 'From Screening up to Day 57 post-dose'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['XEN1101', 'Mass Balance', 'Phase 1'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the mass balance recovery and metabolite profile, and will identify metabolite structures following a single oral dose of 14C-XEN1101 in healthy adult male subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Body mass index (BMI) of 18.0 to 32.0 kg/m2\n* Must be willing and able to communicate and participate in the whole study\n* Provide written informed consent\n* Adhere to the specified contraception requirements\n\nKey Exclusion Criteria:\n\n* Subjects who have received any investigational medicinal product (IMP) in a clinical research study within 90 days\n* Evidence of any current infection or an infection within 14 days before study drug administration\n* History of any drug or alcohol abuse in the past 2 years\n* Subjects with pregnant or lactating partners\n* Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study\n* Participation in a clinical trial involving administration of radiolabelled compound(s) within 180 days of the planned dosing date of this study\n* Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis. Subjects with Gilbert's Syndrome will be excluded.\n* Confirmed positive drugs of abuse test result\n* Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results\n* History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder\n* Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood"}, 'identificationModule': {'nctId': 'NCT04952467', 'briefTitle': 'Single-dose Mass Balance Recovery and Metabolite Profile and Identification of 14C-XEN1101', 'organization': {'class': 'INDUSTRY', 'fullName': 'Xenon Pharmaceuticals Inc.'}, 'officialTitle': 'An Open Label, Single-dose, Single-period Study to Assess the Pharmacokinetics, Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C-XEN1101 in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'XPF-008-103'}, 'secondaryIdInfos': [{'id': '2021-000735-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug: (14C)-XEN1101', 'description': 'Subjects will receive oral 14C-XEN1101 under fed conditions.', 'interventionNames': ['Drug: 14C-XEN1101']}], 'interventions': [{'name': '14C-XEN1101', 'type': 'DRUG', 'description': 'Subjects will receive a single oral administration of a capsule containing 20 mg XEN1101', 'armGroupLabels': ['Drug: (14C)-XEN1101']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG11 6JS', 'city': 'Ruddington', 'state': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Quotient Sciences', 'geoPoint': {'lat': 52.89254, 'lon': -1.14953}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Xenon Pharmaceuticals Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xenon Pharmaceuticals Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}