Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-03-13 @ 7:00 AM
Study NCT ID:
NCT06425003
Status:
COMPLETED
Last Update Posted:
2024-07-19
First Post:
2024-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of [14C] ABBV-CLS-7262 in Healthy Male Volunteers Following Single Oral Dose Administration
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': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2024-05-06', 'studyFirstSubmitQcDate': '2024-05-17', 'lastUpdatePostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events (AEs)', 'timeFrame': 'Up to approximately 30 days from last dose.', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.'}, {'measure': 'Maximum observed concentration (Cmax)', 'timeFrame': 'Up to approximately Day 15 from last dose', 'description': 'Cmax will be assessed.'}, {'measure': 'Time to Cmax (peak time, Tmax)', 'timeFrame': 'Up to approximately 15 days from last dose', 'description': 'Tmax will be assessed.'}, {'measure': 'Terminal phase elimination half-life (t1/2)', 'timeFrame': 'Up to approximately 15 days from last dose', 'description': 'Terminal phase elimination half-life (t1/2) will be assessed.'}, {'measure': 'Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt)', 'timeFrame': 'Up to approximately 15 days from last dose', 'description': 'AUCt will be assessed.'}, {'measure': 'Percent radioactivity excreted', 'timeFrame': 'Up to approximately 15 days from last dose', 'description': 'Percentage total radioactivity'}, {'measure': 'Identification of metabolites excreted', 'timeFrame': 'Up to approximately 15 days from last dose', 'description': 'Identification of the major metabolites'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate mass balance, pharmacokinetics and safety of \\[14C\\] ABBV-CLS-7262 in healthy, male volunteers following administration of a single oral dose.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.\n* Body Max Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at screening.\n\nExclusion Criteria:\n\n* Considering fathering a child or donating sperm during the study and for 94 days after study drug administration, or is unwilling to comply with protocol recommended contraception recommendations.\n* History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.\n* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, hematologic, endocrinologic or psychiatric disease or disorder, or any uncontrolled medical illness.\n* Has had significant exposure to radiation for professional or medical reasons (e.g., serial x-rays or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring), except dental x-rays, within 12 months prior to study drug administration.'}, 'identificationModule': {'nctId': 'NCT06425003', 'briefTitle': 'Study of [14C] ABBV-CLS-7262 in Healthy Male Volunteers Following Single Oral Dose Administration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Calico Life Sciences LLC'}, 'officialTitle': 'Mass Balance Study of [14C] ABBV-CLS-7262 in Healthy Male Volunteers Following Single Oral Dose Administration', 'orgStudyIdInfo': {'id': 'M24-326'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[14C] ABBV-CLS-7262', 'description': 'Participants will receive \\[14C\\] ABBV-CLS-7262 on Day 1.', 'interventionNames': ['Drug: [14C] ABBV-CLS-7262']}], 'interventions': [{'name': '[14C] ABBV-CLS-7262', 'type': 'DRUG', 'description': 'Oral Solution', 'armGroupLabels': ['[14C] ABBV-CLS-7262']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Fortrea Clinical Research Unit Inc.', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Calico Life Sciences LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'AbbVie', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}