Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT02093169
Status:
COMPLETED
Last Update Posted:
2014-09-23
First Post:
2014-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
D2 Dopamine Receptor Occupancy After Oral Dosing of Lu AF35700 in Healthy Men Using [11C]-PHNO as Tracer Compound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'lastUpdateSubmitDate': '2014-09-22', 'studyFirstSubmitDate': '2014-03-19', 'studyFirstSubmitQcDate': '2014-03-19', 'lastUpdatePostDateStruct': {'date': '2014-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relationship between plasma concentrations and pharmacodynamic (PD) measures specified as binding potential at each scanning time point', 'timeFrame': 'Up to 172 hours after dosing'}, {'measure': 'Relationship between plasma concentrations and PD measures specified as plasma concentrations of Lu AF35700, Lu AF36152 and Lu AF35700 + Lu AF36152 at each scanning time point', 'timeFrame': 'Up to 172 hours after dosing'}, {'measure': 'Relationship between plasma concentrations and PD measures specified as occupancy in relation to plasma concentrations of Lu AF35700, Lu AF36152 and Lu AF35700 + Lu AF36152, respectively', 'timeFrame': 'Up to 172 hours after dosing'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'Up to Week 12'}, {'measure': 'Columbia Suicide Severity Rating Scale (C-SSRS) (Part B only)', 'timeFrame': 'Up to Week 12'}, {'measure': 'Area under the curve (AUC), maximum observed concentration (Cmax), oral clearance (CL/F), and apparent elimination half-life (t½)', 'timeFrame': 'Up to 168 hours after dosing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Men']}, 'descriptionModule': {'briefSummary': 'To investigate the relationship between the combined Lu AF35700 and Lu AF36152 plasma concentration and D2 dopamine receptor occupancy up to 172 hours after oral dosing of Lu AF35700'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy young men \\>=25 and \\<=45 years of age with a Body Mass Index (BMI) \\>=18.5 kg/m2 and \\<=30 kg/m2.\n\nOther protocol-defined Inclusion and Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02093169', 'briefTitle': 'D2 Dopamine Receptor Occupancy After Oral Dosing of Lu AF35700 in Healthy Men Using [11C]-PHNO as Tracer Compound', 'organization': {'class': 'INDUSTRY', 'fullName': 'H. Lundbeck A/S'}, 'officialTitle': 'Interventional, Open-label, Positron Emission Tomography (PET) Study Investigating D2 Dopamine Receptor Occupancy After Oral Dosing of Lu AF35700 in Healthy Men Using [11C]-PHNO as Tracer Compound', 'orgStudyIdInfo': {'id': '15868A'}, 'secondaryIdInfos': [{'id': '2013-004283-61', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: Lu AF35700', 'interventionNames': ['Drug: Part A: Lu AF35700']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Lu AF35700', 'interventionNames': ['Drug: Part B: Lu AF35700']}], 'interventions': [{'name': 'Part A: Lu AF35700', 'type': 'DRUG', 'description': 'One 30 mg single dose for one day; orally', 'armGroupLabels': ['Part A: Lu AF35700']}, {'name': 'Part B: Lu AF35700', 'type': 'DRUG', 'description': 'Daily dosing: 10 mg for 3 days, 20 mg for 3 days, 45 mg on Day 7; orally', 'armGroupLabels': ['Part B: Lu AF35700']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NW10 7EW', 'city': 'London', 'country': 'United Kingdom', 'facility': 'GB801', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Email contact via H. Lundbeck A/S', 'role': 'STUDY_DIRECTOR', 'affiliation': 'LundbeckClinicalTrials@lundbeck.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lundbeck A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}