Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-25 @ 3:52 PM
Study NCT ID:
NCT05306366
Status:
COMPLETED
Last Update Posted:
2022-07-14
First Post:
2022-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Brain Imaging PET Study of [11C]-Lu AF90103 in Healthy Adult 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': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-12', 'studyFirstSubmitDate': '2022-03-23', 'studyFirstSubmitQcDate': '2022-03-23', 'lastUpdatePostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Time-Activity Curves for Brain up to 90 Minutes (AUCbrain 0-90 min)', 'timeFrame': 'Day 1 (predose and up to 90 minutes postdose)'}, {'measure': 'Area Under the Blood Concentrations Over Time for [11C]-Lu AF90103 and Radioactive Metabolites up to 90 Minutes (AUCblood 0-90 min)', 'timeFrame': 'Day 1 (predose and up to 90 minutes postdose)'}, {'measure': 'Area Under the Plasma Concentrations Over Time for [11C]-Lu AF90103 and Radioactive Metabolites up to 90 Minutes (AUCplasma 0-90 min)', 'timeFrame': 'Day 1 (predose and up to 90 minutes postdose)'}, {'measure': 'Whole Brain-to-Plasma Ratio Expressed by AUCbrain 0-90 min/AUCplasma 0-90 min', 'timeFrame': 'Day 1 (predose and up to 90 minutes postdose)'}, {'measure': 'Total Distribution Volume in the Whole Brain (VT brain)', 'timeFrame': 'Day 1 (predose and up to 90 minutes postdose)'}, {'measure': 'Ratio Between the Free Concentrations [11C]-Lu AF90103 in Brain Tissue and Plasma (Kp,uu)', 'timeFrame': 'Day 1 (predose and up to 90 minutes postdose)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Young Men']}, 'descriptionModule': {'briefSummary': 'The main goals of the study are to assess uptake and distribution of Lu AF90103 in the brain when given at tracer levels (microdose) in healthy young men.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The participant has a body mass index (BMI) ≥18.5 and ≤30.0 kilograms (kg)/square meter (m\\^2) at the Screening Visit.\n* The participant is, in the opinion of the investigator, generally healthy based on medical history; a physical examination; vital signs; an electrocardiogram (ECG); and the results of the clinical chemistry, hematology, urinalysis, serology, and other laboratory tests.\n\nExclusion Criteria:\n\n* The participant has taken disallowed medication \\<1 week prior to the first dose of study drug or \\<5 half-lives prior to the Screening Visit for any medication taken.\n* The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, hematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.\n* The participant has had surgery or trauma with significant blood loss \\<3 months prior to the first dose of study drug.\n* The participant is exposed to significant levels of ionizing radiation at work. Note: Other inclusion and exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05306366', 'briefTitle': 'A Brain Imaging PET Study of [11C]-Lu AF90103 in Healthy Adult Male Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'H. Lundbeck A/S'}, 'officialTitle': 'Interventional Open-Label Positron Emission Tomography Study Investigating Blood-Brain-Barrier Penetration and Pharmacokinetic Properties of [11C]-Lu AF90103 in Healthy Young Men', 'orgStudyIdInfo': {'id': '19739A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[11C]-Lu AF90103', 'description': 'Participants will receive \\[11C\\]-Lu AF90103 via an intravenous bolus injection on Day 1.', 'interventionNames': ['Drug: [11C]-Lu AF90103']}], 'interventions': [{'name': '[11C]-Lu AF90103', 'type': 'DRUG', 'description': 'PET ligand administrated as a single intravenous bolus injection', 'armGroupLabels': ['[11C]-Lu AF90103']}]}, 'contactsLocationsModule': {'locations': [{'zip': '141 86', 'city': 'Huddinge', 'country': 'Sweden', 'facility': 'Karolinska Trial Alliance', 'geoPoint': {'lat': 59.23705, 'lon': 17.98192}}], 'overallOfficials': [{'name': 'Email contact via H. Lundbeck A/S', 'role': 'STUDY_DIRECTOR', 'affiliation': 'H. Lundbeck A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lundbeck A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}