Ignite Creation Date:
2025-12-25 @ 1:42 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT03565094
Status:
COMPLETED
Last Update Posted:
2019-09-26
First Post:
2018-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Dose of Lu AF28996 to Healthy Young Men
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': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-25', 'studyFirstSubmitDate': '2018-06-08', 'studyFirstSubmitQcDate': '2018-06-20', 'lastUpdatePostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC 0-inf', 'timeFrame': 'From dosing to day 12 postdose', 'description': 'area under the plasma concentration-time curve of Lu AF28996'}, {'measure': 'Cmax', 'timeFrame': 'From dosing to day 12 postdose', 'description': 'maximum observed plasma concentration of Lu AF28996'}, {'measure': 'CL/F', 'timeFrame': 'From dosing to day 12 postdose', 'description': 'Oral clearance of Lu AF28996'}], 'secondaryOutcomes': [{'measure': 'Number of participants with Treatment-Emergent Adverse Events', 'timeFrame': 'From dosing to day 12 postdose', 'description': 'Safety and Tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight and ECG parameters)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study evaluates how increasing doses of Lu AF28996 enters, moves through and exits the body when given by mouth to healthy young men.', 'detailedDescription': 'Part A of the study consists of 6 groups (Cohorts 1 to 6) with 3 subjects in each, with the possibility of 4 additional cohorts. In cohort 1, the subjects will receive a single dose of Lu AF28996 by mouth. Following evaluation of data from the first dose, the subjects in the following cohorts are planned to receive two single increasing doses by mouth of Lu AF28996 on 2 separate days with a wash out (day or days without dosing) in between.\n\nPart B is an open-label three-period crossover study in healthy young men to compare the PK of an oral capsule formulation with that of an oral solution formulation and to evaluate food effect following oral capsule administration of Lu AF28996.The subjects will be randomised to one of the four treatment sequences'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criterium:\n\nHealthy, young, non-smoking men aged ≥18 and ≤45 years and with a body mass index (BMI) ≥18.5kg/m2 and ≤30kg/m2 at the Screening Visit\n\nOther in- and exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT03565094', 'briefTitle': 'Single Dose of Lu AF28996 to Healthy Young Men', 'organization': {'class': 'INDUSTRY', 'fullName': 'H. Lundbeck A/S'}, 'officialTitle': 'Interventional, Open-label, Single- and Sequential-ascending-dose Study Investigating the Safety, Tolerability and Pharmacokinetic Profile of Lu AF28996 in Healthy Young Men', 'orgStudyIdInfo': {'id': '17695A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lu AF28996', 'description': 'Lu AF28996 solution, cohort depending dose\n\nPart A:\n\nCohort 1: single oral dose of Lu AF28996\n\nCohorts 2-6: two single ascending oral doses of Lu AF28996 with a washout in between\n\nPossibility of 4 additional cohorts (Cohorts 7 to 10), allowing for the investigation of a potential 13 additional subjects\n\nPart B: 8 subjects (randomised to one of four treatment sequences)', 'interventionNames': ['Drug: Lu AF28996 solution', 'Drug: Lu AF28996 capsule']}], 'interventions': [{'name': 'Lu AF28996 solution', 'type': 'DRUG', 'description': 'Oral solution (0.1-0.2 mg/mL)\n\nFollowing each cohort, a dosing conference will be held where tolerability, safety and preliminary PK results from the previous cohorts will be reviewed before deciding on the next doses', 'armGroupLabels': ['Lu AF28996']}, {'name': 'Lu AF28996 capsule', 'type': 'DRUG', 'description': 'hard capsule orally QD: one dose lower than the highest dose level in part A', 'armGroupLabels': ['Lu AF28996']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Groningen', 'country': 'Netherlands', 'facility': 'QPS Netherlands BV', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], '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'}}}}