Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT06281158
Status:
COMPLETED
Last Update Posted:
2024-06-20
First Post:
2024-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants
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': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-17', 'studyFirstSubmitDate': '2024-02-20', 'studyFirstSubmitQcDate': '2024-02-26', 'lastUpdatePostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PK Parameter: AUC0-∞', 'timeFrame': '28 days', 'description': 'The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL343 in plasma'}, {'measure': 'PK Parameter: AUC0-tlast', 'timeFrame': '28 days', 'description': 'Area under the concentration-time curve from time zero to the last quantifiable time point (AUC0-tlast) of DNL343 in plasma'}, {'measure': 'PK Parameter: Cmax', 'timeFrame': '28 days', 'description': 'Maximum observed concentration (Cmax) of DNL343 in plasma'}, {'measure': 'PK Parameter: Tmax', 'timeFrame': '28 days', 'description': 'Time to maximum observed concentration (Tmax) of DNL343 in plasma'}, {'measure': 'PK Parameter: t1/2', 'timeFrame': '28 days', 'description': 'Terminal elimination half-life (t1/2) of DNL343 in plasma'}, {'measure': 'Total radioactivity in plasma and whole blood', 'timeFrame': '28 days'}, {'measure': 'Total radioactivity in blood-to-plasma ratio', 'timeFrame': '28 days'}, {'measure': 'Extent and rate of recovery of total radioactivity in urine and feces', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'PK Parameter: AUC0-∞', 'timeFrame': '28 days', 'description': 'The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of a DNL343 metabolite in plasma'}, {'measure': 'PK Parameter: AUC0-tlast', 'timeFrame': '28 days', 'description': 'Area under the concentration-time curve from time zero to the last quantifiable time point (AUC0-tlast) of a DNL343 metabolite in plasma'}, {'measure': 'PK Parameter: Cmax', 'timeFrame': '28 days', 'description': 'Maximum observed concentration (Cmax) of a DNL343 metabolite in plasma'}, {'measure': 'PK Parameter: Tmax', 'timeFrame': '28 days', 'description': 'Time to maximum observed concentration (Tmax) of a DNL343 metabolite in plasma'}, {'measure': 'PK Parameter: t1/2', 'timeFrame': '28 days', 'description': 'Terminal elimination half-life (t1/2) of a DNL343 metabolite in plasma'}, {'measure': 'DNL343 and a DNL343 metabolite recoveries in urine', 'timeFrame': '28 days'}, {'measure': 'Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs)', 'timeFrame': '28 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, open-label, nonrandomized, single-dose study in healthy male participants to investigate the absorption, metabolism and excretion of DNL343.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males, aged between 18 to 65 years, inclusive\n* Body mass index between 18.0 and 32.0 kg/m2\n* In good health\n* When engaging in sex with a woman of child bearing potential, both the male participant and his female partner must use highly effective contraception\n* History of a minimum of 1 bowel movement per day\n\nExclusion Criteria:\n\n* History or clinical manifestation of any clinically significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder\n* Have a history of malignancy, except fully resected basal cell carcinoma\n* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance\n* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs\n* Have previously completed or withdrawn from this study or any other study investigating DNL343 and have previously received DNL343'}, 'identificationModule': {'nctId': 'NCT06281158', 'briefTitle': 'A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Denali Therapeutics Inc.'}, 'officialTitle': 'A Study of the Pharmacokinetics of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants', 'orgStudyIdInfo': {'id': 'DNLI-F-0009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '14C-DNL343', 'interventionNames': ['Drug: [14C]-DNL343']}], 'interventions': [{'name': '[14C]-DNL343', 'type': 'DRUG', 'description': 'Single dose', 'armGroupLabels': ['14C-DNL343']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Ana-Claire Meyer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Denali Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Denali Therapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}