Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-26 @ 6:00 PM
Study NCT ID:
NCT04473651
Status:
TERMINATED
Last Update Posted:
2021-12-14
First Post:
2020-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of Lu AG06479 in Healthy Young Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'whyStopped': 'The study was terminated for strategic reasons.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-30', 'studyFirstSubmitDate': '2020-07-13', 'studyFirstSubmitQcDate': '2020-07-13', 'lastUpdatePostDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment emergent adverse events (Safety and Tolerability)', 'timeFrame': 'From baseline to Day 9 (Part A and B)', 'description': 'Based on the safety assessments (e.g. clinical safety laboratory tests, vital signs, weight and ECG parameters)'}], 'secondaryOutcomes': [{'measure': 'AUC (0-inf) of Lu AG06479', 'timeFrame': 'From pre-dose to Day 5 (Part A and B)', 'description': 'Area under the Lu AG06479 concentration-time curve from time zero to infinity (AUC0-inf)'}, {'measure': 'CL/F Lu AG06479', 'timeFrame': 'From pre-dose to Day 5 (Part A and B)', 'description': 'Oral clearance of Lu AG06479'}, {'measure': 'Cmax Lu AG06479', 'timeFrame': 'From pre-dose to Day 5 (Part A and B)', 'description': 'Maximum observed plasma concentration for Lu AG06479'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the safety and tolerability of Lu AG06479 and what the body does to Lu AG06479 after swallowing single doses of the drug.', 'detailedDescription': 'Part A: randomized, sequential\n\nPart B: open-label, cross-over'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, young, non-smoking men, weight ≥60 kg, and a body mass index (BMI) ≥18.5 kg/m2 and ≤30 kg/m2 at the Screening Visit.\n\nOther in- and exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT04473651', 'briefTitle': 'Safety and Tolerability of Lu AG06479 in Healthy Young Men', 'organization': {'class': 'INDUSTRY', 'fullName': 'H. Lundbeck A/S'}, 'officialTitle': 'Interventional, Randomized, Double-blind, Placebo-controlled, Sequential-group, Single-ascending Oral Dose Study Investigating the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Properties of Lu AG06479 and Open-label Cross-over Study to Investigate Intra-subject Variability and Effect of Food in Healthy Young Men', 'orgStudyIdInfo': {'id': '18452A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: Single dose of Lu AG06479 or Placebo', 'interventionNames': ['Drug: Lu AG06479', 'Drug: Placebos']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Repeated dose of Lu AG06479 and Food interaction', 'description': 'Sequence B1: Fed - Fasting - Fasting\n\nSequence B2: Fasting- Fed - Fasting\n\nSequence B3: Fasting- Fasting - Fed', 'interventionNames': ['Drug: Lu AG06479']}], 'interventions': [{'name': 'Lu AG06479', 'type': 'DRUG', 'otherNames': ['ABX-1762'], 'description': 'capsules, orally (Part A and B)', 'armGroupLabels': ['Part A: Single dose of Lu AG06479 or Placebo', 'Part B: Repeated dose of Lu AG06479 and Food interaction']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'Placebo - capsules, orally (Part A only)', 'armGroupLabels': ['Part A: Single dose of Lu AG06479 or Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Covance', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], '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'}}}}