Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT05742594
Status:
COMPLETED
Last Update Posted:
2023-06-02
First Post:
2023-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Four Different Oral Tablet Formulations of Lazertinib (JNJ-73841937) in Healthy Adult Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000707992', 'term': 'lazertinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-01', 'studyFirstSubmitDate': '2023-02-15', 'studyFirstSubmitQcDate': '2023-02-23', 'lastUpdatePostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interventions A, B and C: Maximum Observed Plasma Concentration (Cmax) of Lazertinib', 'timeFrame': 'Pre dose up to 168 hours post dose', 'description': 'Cmax is defined as maximum observed plasma concentration.'}, {'measure': 'Interventions A, B and C: Area Under the Plasma Concentration-time Curve from Time 0 to 72 Hours (h) (AUC[0-72h]) of Lazertinib', 'timeFrame': 'Pre dose up to 168 hours post dose', 'description': 'AUC (0-72h) is the area under the plasma concentration-time curve from time 0 to 72 hours.'}], 'secondaryOutcomes': [{'measure': 'Interventions A and D: Maximum Observed Plasma Concentration (Cmax) of Lazertinib', 'timeFrame': 'Pre dose up to 168 hours post dose', 'description': 'Cmax is defined as maximum observed plasma concentration.'}, {'measure': 'Interventions A and D: Area Under the Plasma Concentration-time Curve from Time of 0 to 72 Hours [AUC (0-72h)] of Lazertinib', 'timeFrame': 'Pre dose up to 168 hours post dose', 'description': 'AUC (0-72h) is the area under the plasma concentration-time curve from time 0 to 72 hours.'}, {'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to 14 weeks', 'description': 'AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs)', 'timeFrame': 'Up to 14 weeks', 'description': 'A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.'}, {'measure': 'Number of Participants With AEs by Severity', 'timeFrame': 'Up to 14 weeks', 'description': 'Number of participants with AEs by severity will be reported. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.'}, {'measure': 'Number of Participants With Change From Baseline in Clinical Laboratory Test Values', 'timeFrame': 'Up to 14 weeks', 'description': 'Number of participants with change from baseline in clinical laboratory test values (including hematology and clinical chemistry) will be reported.'}, {'measure': 'Number of Participants With Change From Baseline in 12-lead Electrocardiograms (ECGs)', 'timeFrame': 'Up to 14 weeks', 'description': 'Number of participants with change from baseline in 12-lead ECGs will be reported.'}, {'measure': 'Number of Participants With Change From Baseline in Vital Signs', 'timeFrame': 'Up to 14 weeks', 'description': 'Number of participants with change from baselines in vital signs (including temperature \\[oral\\], pulse/heart rate, respiratory rate, and blood pressure) will be reported.'}, {'measure': 'Number of Participants With Change From Baseline in Physical Examination', 'timeFrame': 'Up to 14 weeks', 'description': 'Number of participants with change from baseline in physical examination (including height and body weight) will be reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the bioequivalence of four different lazertinib oral tablet formulations in healthy adult participants under fasted condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy on the basis of physical examination, medical history (at screening only), vital signs, and 12-lead electrocardiogram (ECG) performed at screening and at admission to the study site\n* All female participants must have a negative highly sensitive serum Beta-human chorionic gonadotropin (Beta-HCG) at screening and on Day -1 of Intervention Period 1\n* A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 6 months after receiving the last dose of study intervention\n* Must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study\n* Female participants must be postmenopausal or surgically sterile\n\nExclusion Criteria:\n\n* History of stomach or intestinal surgery or resection, including cholecystectomy, that would potentially alter absorption or excretion of orally administered drugs\n* History of malignancy within 5 years before screening\n* Known allergies, hypersensitivity, or intolerance to lazertinib or its excipients\n* Participant has a history of clinically significant allergies\n* Had major surgery, (for example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from the surgery, or has surgery planned during the time the participant is expected to participate in the study or within 4 weeks after the last dose of study intervention administration'}, 'identificationModule': {'nctId': 'NCT05742594', 'briefTitle': 'A Study of Four Different Oral Tablet Formulations of Lazertinib (JNJ-73841937) in Healthy Adult Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'A Phase 1, Open-label, Randomized, 4-Way Crossover Pivotal Study to Assess the Bioequivalence of Four Different Oral Tablet Formulations of Lazertinib (JNJ-73841937) in Healthy Adult Participants', 'orgStudyIdInfo': {'id': 'CR109315'}, 'secondaryIdInfos': [{'id': '73841937NSC1009', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Sequence: ADBC', 'description': 'Participants will receive intervention A (lazertinib reference formulation) on Day 1 of intervention Period 1, followed by intervention D (lazertinib test formulation) on Day 1 of intervention Period 2, followed by intervention B (lazertinib test formulation) on Day 1 of intervention Period 3 followed by intervention C (lazertinib test formulation) on Day 1 of Intervention Period 4. There will be a wash-out period of at least 14 days and up to 21 days between each intervention period.', 'interventionNames': ['Drug: Lazertinib']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Sequence: BACD', 'description': 'Participants will receive intervention B (lazertinib test formulation) on Day 1 of intervention Period 1, followed by intervention A (lazertinib reference formulation) on Day 1 of intervention Period 2, followed by intervention C (lazertinib test formulation) on Day 1 of intervention Period 3 followed by intervention D (lazertinib test formulation) on Day 1 of intervention Period 4. There will be a wash-out period of at least 14 days and up to 21 days between each intervention period.', 'interventionNames': ['Drug: Lazertinib']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Sequence: CBDA', 'description': 'Participants will receive intervention C (lazertinib test formulation) on Day 1 of intervention Period 1, followed by intervention B (lazertinib test formulation) on Day 1 of intervention Period 2, followed by intervention D (lazertinib test formulation) on Day 1 of intervention Period 3 followed by intervention A (lazertinib reference formulation) on Day 1 of intervention Period 4. There will be a wash-out period of at least 14 days and up to 21 days between each intervention period.', 'interventionNames': ['Drug: Lazertinib']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Sequence: DCAB', 'description': 'Participants will receive intervention D (lazertinib test formulation) on Day 1 of intervention Period 1, followed by intervention C (lazertinib test formulation) on Day 1 of intervention Period 2, followed by intervention A (lazertinib reference formulation) on Day 1 of intervention Period 3 followed by intervention B (lazertinib test formulation) on Day 1 of intervention Period 4. There will be a wash-out period of at least 14 days and up to 21 days between each intervention period.', 'interventionNames': ['Drug: Lazertinib']}], 'interventions': [{'name': 'Lazertinib', 'type': 'DRUG', 'otherNames': ['JNJ-73841937'], 'description': 'Lazertinib will be administered orally.', 'armGroupLabels': ['Intervention Sequence: ADBC', 'Intervention Sequence: BACD', 'Intervention Sequence: CBDA', 'Intervention Sequence: DCAB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Celerion', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}], 'overallOfficials': [{'name': 'Janssen Research & Development, LLC Clinical Trail', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Research & Development, LLC'}]}, 'ipdSharingStatementModule': {'url': 'https://www.janssen.com/clinical-trials/transparency', 'ipdSharing': 'YES', 'description': 'The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \\& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}