Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-02-18 @ 10:26 PM
Study NCT ID:
NCT04104503
Status:
COMPLETED
Last Update Posted:
2020-04-17
First Post:
2019-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Investigating Tablet Formulations of Lu AF11167 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-16', 'studyFirstSubmitDate': '2019-09-24', 'studyFirstSubmitQcDate': '2019-09-24', 'lastUpdatePostDateStruct': {'date': '2020-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax of Lu AF11167', 'timeFrame': 'From 0 to 48 hours', 'description': 'Maximum observed plasma concentration'}, {'measure': 'AUC(0-inf) of Lu AF11167', 'timeFrame': 'From 0 to 48 hours', 'description': 'Area under the plasma concentration time curve from zero to infinity'}, {'measure': 'Relative bioavailability F(rel) of Lu AF11167', 'timeFrame': 'From 0 to 48 hours', 'description': 'F(rel) is estimated as the dose normalized AUC(inf) for the test formulation relative to the reference formulation (part A only)'}, {'measure': 'Absolute bioavailability F(abs) of Lu AF11167', 'timeFrame': 'From 0 to 48 hours', 'description': 'F(abs) is estimated as the dose normalized AUC(inf) for the test formulation relative to the intravenous reference formulation (part B only)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the extent to which Lu AF11167 enters the bloodstream following tablet intake and the influence of food on uptake in healthy men and women', 'detailedDescription': 'This study will be split into Part A and Part B. Part A will happen first and will look at new tablet formulations of the test medicine compared to a previously known formulation (reference tablet). The results from Part A of the study will be used to decide which formulation will be tested in Part B of the study. Part B of the study will look at the food effect, variability between participants, and absolute bioavailability of the test medicine i.e. how much of the test medicine is taken up by the body when dosed by mouth compared to when dosed once by injection directly into the vein. Safety and tolerability will be assessed throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) of ≥18.5 and ≤30.0 kg/m2\n* (Part B only) Women of child-bearing potential will have a confirmed non-pregnant and non-lactating status\n\nExclusion Criteria:\n\n* The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the investigational medical product\n\nOther in- and exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT04104503', 'briefTitle': 'A Study Investigating Tablet Formulations of Lu AF11167 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'H. Lundbeck A/S'}, 'officialTitle': 'Interventional, Open-label, Two-part, Partly-randomized Study Investigating the Pharmacokinetic Properties, Absolute Bioavailability, Food Effect, and Intra-subject Variability of up to 5 Prototype Modified-release Tablet Formulations of Lu AF11167 in Healthy Subjects', 'orgStudyIdInfo': {'id': '18153A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A', 'interventionNames': ['Drug: Lu AF11167']}, {'type': 'EXPERIMENTAL', 'label': 'Part B group 1', 'description': 'Treatment period 1: Fasted + iv;\n\nTreatment period 2: Fasted;\n\nTreatment period 3: High-fat meal', 'interventionNames': ['Drug: [14C]-Lu AF11167', 'Drug: Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation)']}, {'type': 'EXPERIMENTAL', 'label': 'Part B group 2', 'description': 'Treatment period 1: High-fat meal;\n\nTreatment period 2: Fasted + iv;\n\nTreatment period 3: Fasted', 'interventionNames': ['Drug: [14C]-Lu AF11167', 'Drug: Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation)']}, {'type': 'EXPERIMENTAL', 'label': 'Part B group 3', 'description': 'Treatment period 1: Fasted;\n\nTreatment period 2: High-fat meal;\n\nTreatment period 3: Fasted + iv', 'interventionNames': ['Drug: [14C]-Lu AF11167', 'Drug: Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation)']}], 'interventions': [{'name': 'Lu AF11167', 'type': 'DRUG', 'description': 'Lu AF11167 - 2 mg modified release tablets (reference formulation), up to 5 prototype MR tablet formulations (test formulations)', 'armGroupLabels': ['Part A']}, {'name': '[14C]-Lu AF11167', 'type': 'DRUG', 'description': 'single iv microdose administered as a 15 minutes infusion', 'armGroupLabels': ['Part B group 1', 'Part B group 2', 'Part B group 3']}, {'name': 'Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation)', 'type': 'DRUG', 'description': 'Single oral dose', 'armGroupLabels': ['Part B group 1', 'Part B group 2', 'Part B group 3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Quotient', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Email contact via H. Lundbeck A/S', 'role': 'STUDY_DIRECTOR', 'affiliation': 'LundbeckClinicalTrials@Lundbeck.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lundbeck A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}